Trial Outcomes & Findings for A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies (NCT NCT02108964)
NCT ID: NCT02108964
Last Updated: 2024-12-11
Results Overview
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
225 participants
Primary outcome timeframe
First 28 days of dosing
Results posted on
2024-12-11
Participant Flow
This is a 2-part study conducted in 14 investigative sites in 9 countries: Phase I part (dose-escalation) and Phase II part (dose expansion)
370 subjects were screened for eligibility during the 28 days prior to starting study treatment on Cycle 1 Day 1 (C1D1). The eligibility assessments were performed and ensured that all inclusion and exclusion criteria were satisfied
Participant milestones
| Measure |
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
38
|
73
|
8
|
28
|
5
|
11
|
45
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
38
|
73
|
8
|
28
|
5
|
11
|
45
|
Reasons for withdrawal
| Measure |
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
15
|
31
|
54
|
7
|
20
|
4
|
6
|
33
|
|
Overall Study
Physician Decision
|
1
|
5
|
7
|
1
|
2
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
0
|
1
|
0
|
3
|
2
|
|
Overall Study
Death
|
1
|
1
|
4
|
0
|
3
|
0
|
0
|
2
|
|
Overall Study
Subject/Guardian decision
|
0
|
1
|
4
|
0
|
2
|
0
|
1
|
2
|
|
Overall Study
Study terminated by Sponsor: remaining participants benefiting from drug were transitioned to PSDS
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Baseline characteristics by cohort
| Measure |
EGF816 75 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=73 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=28 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
133 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
92 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
143 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
82 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
147 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
69 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: First 28 days of dosingPopulation: Dose-determining set (DDS) including all patients who received at least one dose of EGF816 in the dose escalation phase who had met the minimum safety evaluation requirements (observed for ≥ 28 days following the first dose) and the minimum exposure criterion (at least 75% of the planned doses of EGF816) or discontinue earlier due to DLTs
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=16 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=69 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=7 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=23 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=2 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=9 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) (Phase I Part)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From baseline up to 64 weeksPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) determined by BIRC assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=45 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) (Phase II Part)
|
64.4 Percentage of participants
Interval 48.8 to 78.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=12 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=34 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=68 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=24 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) by Investigator Assessment (Phase I & Phase II Parts)
|
6.3 Months
Interval 1.54 to 47.8
|
12.1 Months
Interval 7.16 to 16.56
|
7.4 Months
Interval 5.32 to 9.59
|
13.7 Months
Interval 3.52 to 27.47
|
11.1 Months
Interval 7.23 to 23.49
|
11.8 Months
Interval 5.62 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
11.0 Months
Interval 0.43 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
18.2 Months
Interval 11.04 to 30.16
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=34 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=15 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=3 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=4 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=29 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) by Investigator Assessment (Phase I & II Parts)
|
46.2 Months
Interval 3.68 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
11.3 Months
Interval 7.39 to 23.79
|
7.9 Months
Interval 7.39 to 11.04
|
14.9 Months
Interval 9.2 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
16.5 Months
Interval 5.52 to 29.63
|
10.2 Months
Interval 9.33 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
17.5 Months
Interval 7.56 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
20.3 Months
Interval 11.01 to 34.89
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).Population: Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
To characterize the PK properties of EGF816 and metabolite LMI258, Cmax will be calculated (Phase I \& II parts). Cmax is maximum (peak) observed plasma drug concentration (mass x volume-1).
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=72 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=28 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C1D1
|
14.1 ng/mL
Geometric Coefficient of Variation 174.8
|
11.4 ng/mL
Geometric Coefficient of Variation 76.1
|
25.2 ng/mL
Geometric Coefficient of Variation 61.7
|
30.9 ng/mL
Geometric Coefficient of Variation 64.6
|
42.0 ng/mL
Geometric Coefficient of Variation 63.1
|
62.2 ng/mL
Geometric Coefficient of Variation 40.5
|
52.7 ng/mL
Geometric Coefficient of Variation 42.1
|
24.3 ng/mL
Geometric Coefficient of Variation 46.6
|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: Cycle (C) 1 Day (D) 1
|
333 ng/mL
Geometric Coefficient of Variation 64.9
|
301 ng/mL
Geometric Coefficient of Variation 81.8
|
541 ng/mL
Geometric Coefficient of Variation 53.2
|
641 ng/mL
Geometric Coefficient of Variation 60.2
|
935 ng/mL
Geometric Coefficient of Variation 66.1
|
1070 ng/mL
Geometric Coefficient of Variation 58.3
|
1190 ng/mL
Geometric Coefficient of Variation 50.0
|
471 ng/mL
Geometric Coefficient of Variation 41.2
|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: C1D15
|
402 ng/mL
Geometric Coefficient of Variation 62.3
|
477 ng/mL
Geometric Coefficient of Variation 53.0
|
765 ng/mL
Geometric Coefficient of Variation 50.1
|
939 ng/mL
Geometric Coefficient of Variation 45.4
|
1320 ng/mL
Geometric Coefficient of Variation 46.0
|
2670 ng/mL
Geometric Coefficient of Variation NA
NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
1530 ng/mL
Geometric Coefficient of Variation 23.5
|
—
|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: C2D1
|
348 ng/mL
Geometric Coefficient of Variation 43.4
|
426 ng/mL
Geometric Coefficient of Variation 50.1
|
767 ng/mL
Geometric Coefficient of Variation 46.7
|
938 ng/mL
Geometric Coefficient of Variation 53.9
|
1270 ng/mL
Geometric Coefficient of Variation 61.0
|
1700 ng/mL
Geometric Coefficient of Variation 41.3
|
1270 ng/mL
Geometric Coefficient of Variation 30.4
|
648 ng/mL
Geometric Coefficient of Variation 50.9
|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C1D15
|
31.2 ng/mL
Geometric Coefficient of Variation 94.7
|
34.1 ng/mL
Geometric Coefficient of Variation 81.8
|
72.2 ng/mL
Geometric Coefficient of Variation 64.0
|
113 ng/mL
Geometric Coefficient of Variation 54.1
|
131 ng/mL
Geometric Coefficient of Variation 56.8
|
292 ng/mL
Geometric Coefficient of Variation NA
NA = NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
164 ng/mL
Geometric Coefficient of Variation 22.7
|
—
|
|
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C2D1
|
23.9 ng/mL
Geometric Coefficient of Variation 59.5
|
32.4 ng/mL
Geometric Coefficient of Variation 76.0
|
81.4 ng/mL
Geometric Coefficient of Variation 55.4
|
114 ng/mL
Geometric Coefficient of Variation 75.1
|
101 ng/mL
Geometric Coefficient of Variation 72.8
|
142 ng/mL
Geometric Coefficient of Variation 55.1
|
116 ng/mL
Geometric Coefficient of Variation 68.7
|
62.5 ng/mL
Geometric Coefficient of Variation 60.7
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).Population: Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
To characterize the PK properties of EGF816 and metabolite LMI258, Tmax will be calculated (Phase I \& II parts). Tmax is the time to reach maximum (peak) plasma drug concentration (time).
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=69 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=28 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=43 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
EFG816: Cycle (C) 1 Day (D) 1
|
2.83 hour (hr)
Geometric Coefficient of Variation 63.0
|
3.24 hour (hr)
Geometric Coefficient of Variation 42.7
|
2.74 hour (hr)
Geometric Coefficient of Variation 54.7
|
3.66 hour (hr)
Geometric Coefficient of Variation 74.1
|
2.64 hour (hr)
Geometric Coefficient of Variation 64.9
|
3.37 hour (hr)
Geometric Coefficient of Variation 41.0
|
3.45 hour (hr)
Geometric Coefficient of Variation 22.4
|
2.81 hour (hr)
Geometric Coefficient of Variation 43.4
|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
EFG816: C1D15
|
2.91 hour (hr)
Geometric Coefficient of Variation 57.7
|
2.75 hour (hr)
Geometric Coefficient of Variation 75.8
|
3.11 hour (hr)
Geometric Coefficient of Variation 46.4
|
3.52 hour (hr)
Geometric Coefficient of Variation 44.3
|
3.46 hour (hr)
Geometric Coefficient of Variation 36.1
|
6.08 hour (hr)
Geometric Coefficient of Variation NA
NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
4.45 hour (hr)
Geometric Coefficient of Variation 35.4
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
LMI258: C1D1
|
2.54 hour (hr)
Geometric Coefficient of Variation 65.7
|
3.14 hour (hr)
Geometric Coefficient of Variation 43.6
|
2.78 hour (hr)
Geometric Coefficient of Variation 65.2
|
3.19 hour (hr)
Geometric Coefficient of Variation 73.6
|
2.99 hour (hr)
Geometric Coefficient of Variation 71.4
|
3.37 hour (hr)
Geometric Coefficient of Variation 41.5
|
3.53 hour (hr)
Geometric Coefficient of Variation 31.8
|
2.70 hour (hr)
Geometric Coefficient of Variation 43.3
|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
LMI258: C1D15
|
2.89 hour (hr)
Geometric Coefficient of Variation 55.1
|
2.76 hour (hr)
Geometric Coefficient of Variation 63.8
|
3.32 hour (hr)
Geometric Coefficient of Variation 54.7
|
4.05 hour (hr)
Geometric Coefficient of Variation 32.6
|
4.03 hour (hr)
Geometric Coefficient of Variation 38.7
|
7.12 hour (hr)
Geometric Coefficient of Variation NA
NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
4.54 hour (hr)
Geometric Coefficient of Variation 39.3
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
LMI258: C2D1
|
3.38 hour (hr)
Geometric Coefficient of Variation 64.7
|
3.04 hour (hr)
Geometric Coefficient of Variation 57.6
|
3.43 hour (hr)
Geometric Coefficient of Variation 55.0
|
5.00 hour (hr)
Geometric Coefficient of Variation 56.1
|
3.26 hour (hr)
Geometric Coefficient of Variation 46.6
|
3.77 hour (hr)
Geometric Coefficient of Variation 42.4
|
4.13 hour (hr)
Geometric Coefficient of Variation 47.8
|
3.92 hour (hr)
Geometric Coefficient of Variation 45.5
|
|
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
EFG816: C2D1
|
3.13 hour (hr)
Geometric Coefficient of Variation 44.7
|
2.81 hour (hr)
Geometric Coefficient of Variation 49.0
|
3.14 hour (hr)
Geometric Coefficient of Variation 54.0
|
3.53 hour (hr)
Geometric Coefficient of Variation 35.3
|
3.17 hour (hr)
Geometric Coefficient of Variation 38.2
|
2.99 hour (hr)
Geometric Coefficient of Variation 0.6
|
3.97 hour (hr)
Geometric Coefficient of Variation 44.1
|
3.48 hour (hr)
Geometric Coefficient of Variation 52.7
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).Population: Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
To characterize the PK properties of EGF816 and metabolite LMI258, AUCtau will be calculated (Phase I \& II parts). AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1).
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=72 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=28 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: Cycle (C) 1 Day (D) 1
|
4340 ng*hr/mL
Geometric Coefficient of Variation 68.2
|
4000 ng*hr/mL
Geometric Coefficient of Variation 83.1
|
6880 ng*hr/mL
Geometric Coefficient of Variation 53.3
|
8310 ng*hr/mL
Geometric Coefficient of Variation 51.2
|
12100 ng*hr/mL
Geometric Coefficient of Variation 64.7
|
15000 ng*hr/mL
Geometric Coefficient of Variation 61.0
|
16900 ng*hr/mL
Geometric Coefficient of Variation 51.0
|
5720 ng*hr/mL
Geometric Coefficient of Variation 42.7
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: C1D15
|
6370 ng*hr/mL
Geometric Coefficient of Variation 61.1
|
6770 ng*hr/mL
Geometric Coefficient of Variation 66.0
|
11300 ng*hr/mL
Geometric Coefficient of Variation 53.2
|
13500 ng*hr/mL
Geometric Coefficient of Variation 44.1
|
20300 ng*hr/mL
Geometric Coefficient of Variation 54.6
|
51200 ng*hr/mL
Geometric Coefficient of Variation NA
NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
25700 ng*hr/mL
Geometric Coefficient of Variation 26.1
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
EFG816: C2D1
|
5670 ng*hr/mL
Geometric Coefficient of Variation 44.7
|
6150 ng*hr/mL
Geometric Coefficient of Variation 58.6
|
11800 ng*hr/mL
Geometric Coefficient of Variation 50.3
|
15800 ng*hr/mL
Geometric Coefficient of Variation 10.6
|
18600 ng*hr/mL
Geometric Coefficient of Variation 66.5
|
26100 ng*hr/mL
Geometric Coefficient of Variation 53.0
|
22300 ng*hr/mL
Geometric Coefficient of Variation 19.0
|
9830 ng*hr/mL
Geometric Coefficient of Variation 51.3
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C1D1
|
182 ng*hr/mL
Geometric Coefficient of Variation 56.8
|
162 ng*hr/mL
Geometric Coefficient of Variation 78.0
|
330 ng*hr/mL
Geometric Coefficient of Variation 62.1
|
424 ng*hr/mL
Geometric Coefficient of Variation 56.0
|
559 ng*hr/mL
Geometric Coefficient of Variation 62.4
|
859 ng*hr/mL
Geometric Coefficient of Variation 50.0
|
810 ng*hr/mL
Geometric Coefficient of Variation 47.0
|
291 ng*hr/mL
Geometric Coefficient of Variation 45.3
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C1D15
|
466 ng*hr/mL
Geometric Coefficient of Variation 82.1
|
523 ng*hr/mL
Geometric Coefficient of Variation 111.1
|
1170 ng*hr/mL
Geometric Coefficient of Variation 69.5
|
1810 ng*hr/mL
Geometric Coefficient of Variation 58.6
|
2460 ng*hr/mL
Geometric Coefficient of Variation 65.2
|
5940 ng*hr/mL
Geometric Coefficient of Variation NA
NA = Geo CV% could not be reached due to the low number of participants analyzed.
|
3420 ng*hr/mL
Geometric Coefficient of Variation 45.6
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
LMI258: C2D1
|
402 ng*hr/mL
Geometric Coefficient of Variation 65.7
|
499 ng*hr/mL
Geometric Coefficient of Variation 97.7
|
1380 ng*hr/mL
Geometric Coefficient of Variation 58.6
|
2340 ng*hr/mL
Geometric Coefficient of Variation 45.2
|
1760 ng*hr/mL
Geometric Coefficient of Variation 90.3
|
2360 ng*hr/mL
Geometric Coefficient of Variation 65.9
|
2820 ng*hr/mL
Geometric Coefficient of Variation 34.8
|
1060 ng*hr/mL
Geometric Coefficient of Variation 67.7
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 Day 15Population: Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
Changes in EGFR signaling pathway of newly obtained tumor samples following EGF816 treatment were evaluated by IHC of three pharmacodynamics (PD) biomarkers: p-EGFR, p-AKT and p-ERK. The assigned H-score semi-quantitatively assessed the expression level of these protein markers and their phosphorylated forms.
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=2 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=10 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=4 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=9 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=2 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=4 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
Pharmacodynamics (PD) parameter: P_AKT: % Change from baseline in H-Score
|
-10.0 percentage change
Standard Deviation NA
NA = SD could not be calculated due to the low number of participants analyzed.
|
-39.0 percentage change
Standard Deviation 78.2
|
-31.8 percentage change
Standard Deviation 47.7
|
3.5 percentage change
Standard Deviation 14.5
|
16.1 percentage change
Standard Deviation 65.3
|
-2.5 percentage change
Standard Deviation 3.5
|
-51.3 percentage change
Standard Deviation 71.9
|
—
|
|
Percentage Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
PD parameter: p-EGFR: % Change from baseline in H-Score
|
-165.0 percentage change
Standard Deviation NA
NA = SD could not be calculated due to the low number of participants analyzed.
|
-21.8 percentage change
Standard Deviation 43.9
|
-19.5 percentage change
Standard Deviation 34.7
|
-38.8 percentage change
Standard Deviation 50.1
|
2.2 percentage change
Standard Deviation 23.7
|
-32.5 percentage change
Standard Deviation 38.9
|
-12.5 percentage change
Standard Deviation 18.9
|
—
|
|
Percentage Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
PD parameter: p-ERK: % Change from baseline in H-Score
|
-60.0 percentage change
Standard Deviation NA
NA = SD could not be calculated due to the low number of participants analyzed.
|
-113.4 percentage change
Standard Deviation 84.2
|
-2.4 percentage change
Standard Deviation 128.3
|
33.5 percentage change
Standard Deviation 86.7
|
8.8 percentage change
Standard Deviation 68.0
|
-65.0 percentage change
Standard Deviation 35.4
|
-1.3 percentage change
Standard Deviation 46.6
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 4 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
ORR is defined as percentage of patients with best overall response of partial response (PR)+ complete response (CR) determined by Investigator assessment in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=12 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=34 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=68 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=24 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) by Investigator Assessment (Phase I & II Parts)
|
41.7 Percentage of participants
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
62.5 Percentage of participants
|
60.0 Percentage of participants
|
36.4 Percentage of participants
|
55.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 4 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
DCR is defined as the proportion of patients with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=12 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=34 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=68 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=24 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) by Investigator Assessment (Phase I & II Parts)
|
83.3 Percentage of participants
|
97.1 Percentage of participants
|
83.3 Percentage of participants
|
100.0 Percentage of participants
|
95.8 Percentage of participants
|
100.0 Percentage of participants
|
72.7 Percentage of participants
|
91.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=12 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=34 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=68 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=24 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR) by Investigator Assessment (Phase I & II Parts)
|
NA Months
Interval 1.64 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
5.5 Months
Interval 1.81 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
11.6 Months
Interval 1.87 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
4.5 Months
Interval 1.64 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
1.9 Months
Interval 1.68 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
1.7 Months
Interval 1.61 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
NA Months
Interval 1.64 to
NA = the upper limit of CI was not reached as there were not enough events observed
|
1.9 Months
Interval 1.84 to 7.16
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Safety Set: The Safety Set includes all subjects who received at least one dose of EGF816.
Assessment of the tolerability of EGF816 will be performed continuously during the treatment phase
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=17 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
n=38 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
n=73 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
n=8 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
n=28 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
n=5 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
n=11 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 Participants
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Interruptions and Dose Reductions (Phase I & II Parts)
Participants with any dose Interruption
|
3 Participants
|
17 Participants
|
35 Participants
|
5 Participants
|
20 Participants
|
5 Participants
|
6 Participants
|
19 Participants
|
|
Number of Participants With Dose Interruptions and Dose Reductions (Phase I & II Parts)
Participants with at least one dose reductions
|
0 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
17 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=30 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) by BIRC (Phase II Part)
|
18.6 Months
Interval 14.88 to 31.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
DCR is defined as the percentage of patients with best overall response of CR, PR, or SD determined by BIRC in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=45 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) by BIRC (Phase II Part)
|
93.3 Percentage of participants
Interval 81.7 to 98.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=45 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) by BIRC (Phase II Part)
|
18.9 months
Interval 14.75 to 29.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
TTR is defined as as the time from the date of first dose of study treatment to the date of first documented response (CR or PR) determined by by BIRC in accordance to RECIST 1.1
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=45 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR) by BIRC (Phase II Part)
|
48.3 Months
Interval 22.93 to 58.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 24 weeks up to approx. 9 yearsPopulation: Full Analysis Set (FAS) including participants who received at least one dose of EGF816
OS is defined as the time from first dose of the study treatment to the date of death due to any cause.
Outcome measures
| Measure |
EGF816 75 mg (Phase I Part)
n=45 Participants
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) (Phase II Part)
|
48.3 Months
Interval 22.93 to 58.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
EGF816 75 mg (Phase l Part)
Serious events: 7 serious events
Other events: 17 other events
Deaths: 3 deaths
EGF816 100 mg (Phase l Part)
Serious events: 11 serious events
Other events: 36 other events
Deaths: 1 deaths
EGF816 150 mg (Phase l Part)
Serious events: 40 serious events
Other events: 73 other events
Deaths: 13 deaths
EGF816 200 mg (Phase l Part)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
EGF8166 225 mg (Phase l Part)
Serious events: 16 serious events
Other events: 28 other events
Deaths: 7 deaths
EGF816 300 mg (Phase l Part)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
EGF816 350 mg (Phase l Part)
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
EGF816 150 mg (Phase II Part)
Serious events: 22 serious events
Other events: 42 other events
Deaths: 6 deaths
All Subjects
Serious events: 107 serious events
Other events: 220 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
EGF816 75 mg (Phase l Part)
n=17 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase l Part)
n=38 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase l Part)
n=73 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase l Part)
n=8 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF8166 225 mg (Phase l Part)
n=28 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase l Part)
n=5 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase l Part)
n=11 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 participants at risk
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
All Subjects
n=225 participants at risk
All subjects in the phase l and phase ll parts of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Face oedema
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Appendicitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Empyema
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Meningitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.2%
6/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.3%
21/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Septic shock
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Hepatitis B DNA assay positive
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Product Issues
Device dislocation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Major depression
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.1%
7/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
EGF816 75 mg (Phase l Part)
n=17 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 100 mg (Phase l Part)
n=38 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase l Part)
n=73 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 200 mg (Phase l Part)
n=8 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF8166 225 mg (Phase l Part)
n=28 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 300 mg (Phase l Part)
n=5 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 350 mg (Phase l Part)
n=11 participants at risk
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
|
EGF816 150 mg (Phase II Part)
n=45 participants at risk
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
|
All Subjects
n=225 participants at risk
All subjects in the phase l and phase ll parts of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.2%
5/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.7%
10/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
7/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
60.0%
3/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
36.4%
4/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.6%
35/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.1%
7/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Dry eye
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Eye discharge
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Lacrimation increased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
16/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
13/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Ascites
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.3%
10/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.3%
17/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.8%
8/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.7%
42/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
34.2%
13/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
39.7%
29/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
50.0%
4/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
60.7%
17/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
100.0%
5/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
81.8%
9/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
46.7%
21/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
45.3%
102/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
15/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.9%
11/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.1%
8/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.5%
15/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
35.7%
10/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
22.2%
10/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
24.0%
54/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
47.1%
8/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.7%
9/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.4%
20/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
39.3%
11/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.7%
12/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
29.8%
67/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.7%
10/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.6%
8/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.9%
38/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
13/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest discomfort
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chills
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Early satiety
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
47.1%
8/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.1%
8/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.8%
21/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.6%
8/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
60.0%
3/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.2%
59/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Gait disturbance
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Influenza like illness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.7%
10/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.0%
18/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.2%
5/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
11/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.0%
27/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.0%
8/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.4%
6/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.7%
12/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
34/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Swelling face
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Xerosis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Folliculitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Genital herpes
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Herpes zoster
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
6/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.8%
22/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Paronychia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.4%
12/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
36.4%
4/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.2%
32/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
12/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Rash pustular
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.1%
7/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Tonsillitis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.7%
9/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.6%
7/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
7/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.6%
7/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.0%
36/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.6%
7/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.4%
19/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Wound infection
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Radius fracture
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.6%
17/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Amylase increased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
6/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.0%
18/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatinine increased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
16/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
6/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.9%
11/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
12/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Weight decreased
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
13/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.4%
5/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.9%
16/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
7/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
45.5%
5/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.9%
13/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
24.0%
54/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.9%
11/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.1%
7/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.3%
9/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.6%
7/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.6%
26/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
4/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
11/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.9%
5/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
34/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
11/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.6%
26/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.4%
7/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.6%
17/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.2%
6/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
16/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.2%
6/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.0%
8/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
20/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Amnesia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Aphasia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dementia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.8%
6/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.3%
9/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.2%
32/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
4/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.1%
7/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.4%
7/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.8%
13/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.4%
6/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
9/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
41/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depressed mood
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.0%
8/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.8%
22/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.4%
5/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.4%
7/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.8%
21/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
3/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
35.7%
10/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
31.1%
14/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.4%
64/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.3%
6/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.8%
13/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.6%
8/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
6/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.0%
36/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.2%
6/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.9%
11/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
16/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.3%
2/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
6/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.0%
8/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.4%
6/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.4%
19/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
9/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.0%
8/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.9%
5/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.3%
3/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
22.2%
10/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.1%
34/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.7%
9/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.5%
15/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
39.3%
11/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
60.0%
3/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
45.5%
5/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
5/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.1%
52/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
3/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
10/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.89%
2/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
4/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.9%
11/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
38.4%
28/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
62.5%
5/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
42.9%
12/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
60.0%
3/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
54.5%
6/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
28.9%
13/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
36.4%
82/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
4/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.8%
8/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
24/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
2/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
2/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
2/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
15/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.5%
4/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.7%
9/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
39.7%
29/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
50.0%
4/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
53.6%
15/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
100.0%
5/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
54.5%
6/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.8%
17/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
39.6%
89/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
1/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
3/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
5/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.1%
3/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.7%
3/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
1/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.2%
1/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
8/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
5.9%
1/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
17.6%
3/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
1/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.8%
5/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
14.3%
4/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.2%
2/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
3/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.4%
19/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.44%
1/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.5%
4/38 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
2/73 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
12.5%
1/8 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.1%
2/28 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/5 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.1%
1/11 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
17.8%
8/45 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.9%
20/225 • Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER