Trial Outcomes & Findings for Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform (NCT NCT00977431)
NCT ID: NCT00977431
Last Updated: 2019-02-18
Results Overview
Adverse event (AE) related to afatinib with any one criteria; Hematological: Common terminology criteria for adverse events (CTCAE) Grade 4 neutropenia (Absolute neutrophil count, including bands \<500/cubic millimeter (mm³)) for \>7 days, CTCAE Grade 3 or 4 neutropenia of any duration associated with fever \>38.3 Celsius, CTCAE Grade 3 thrombocytopenia (platelet count \<50000 - 25000/mm³), All other toxicities of CTCAE Grade ≥3 leading interruption of treatment \> 14 days. Non-hematological: CTCAE Grade ≥3 nausea or vomiting despite appropriate use of standard anti-emetics for ≥3 days, CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for ≥3 days, CTCAE Grade ≥3 rash despite standard medical management and lasting \>7 days, CTCAE Grade ≥2 cardiac left ventricular function, CTCAE Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria or decrease in glomerular filtration rate, All other toxicities of CTCAE Grade ≥3.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-02-18
Participant Flow
This is phase I, open-label, non-randomised, uncontrolled dose-escalation trial using a rule-based 3+3 design and patient stratification to explore safety of combining afatinib and radiotherapy with or without temozolomide in newly diagnosed Glioblastoma multiforme (GBM)
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
3
|
13
|
|
Overall Study
Discontinued Afatinib Before/on Day 42
|
1
|
0
|
4
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
3
|
13
|
Reasons for withdrawal
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Overall Study
Other than listed
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
4
|
0
|
6
|
|
Overall Study
Dose-limiting toxicity (DLT)
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive disease
|
2
|
6
|
1
|
3
|
5
|
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 Participants
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 15.7 • n=5 Participants • Treated Set
|
52.7 Years
STANDARD_DEVIATION 7.1 • n=7 Participants • Treated Set
|
56.0 Years
STANDARD_DEVIATION 9.1 • n=5 Participants • Treated Set
|
52.0 Years
STANDARD_DEVIATION 3.6 • n=4 Participants • Treated Set
|
55.2 Years
STANDARD_DEVIATION 9.3 • n=21 Participants • Treated Set
|
53.4 Years
STANDARD_DEVIATION 10.1 • n=10 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • Treated Set
|
2 Participants
n=7 Participants • Treated Set
|
2 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
5 Participants
n=21 Participants • Treated Set
|
11 Participants
n=10 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants • Treated Set
|
4 Participants
n=7 Participants • Treated Set
|
5 Participants
n=5 Participants • Treated Set
|
3 Participants
n=4 Participants • Treated Set
|
8 Participants
n=21 Participants • Treated Set
|
25 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Treated Set
|
1 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
1 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants • Treated Set
|
5 Participants
n=7 Participants • Treated Set
|
7 Participants
n=5 Participants • Treated Set
|
3 Participants
n=4 Participants • Treated Set
|
13 Participants
n=21 Participants • Treated Set
|
35 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined.
Adverse event (AE) related to afatinib with any one criteria; Hematological: Common terminology criteria for adverse events (CTCAE) Grade 4 neutropenia (Absolute neutrophil count, including bands \<500/cubic millimeter (mm³)) for \>7 days, CTCAE Grade 3 or 4 neutropenia of any duration associated with fever \>38.3 Celsius, CTCAE Grade 3 thrombocytopenia (platelet count \<50000 - 25000/mm³), All other toxicities of CTCAE Grade ≥3 leading interruption of treatment \> 14 days. Non-hematological: CTCAE Grade ≥3 nausea or vomiting despite appropriate use of standard anti-emetics for ≥3 days, CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for ≥3 days, CTCAE Grade ≥3 rash despite standard medical management and lasting \>7 days, CTCAE Grade ≥2 cardiac left ventricular function, CTCAE Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria or decrease in glomerular filtration rate, All other toxicities of CTCAE Grade ≥3.
Outcome measures
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=5 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 Participants
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=6 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Number of Patients With Investigator Defined Dose Limiting Toxicities (DLT) During the RT Phase
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined.
The MTD was defined as the highest afatinib dose level, at which no more than 1 out of 6 patients experienced drug-related DLT, i.e. the highest afatinib dose with a DLT incidence ≤17%. A separate MTD was determined for afatinib and RT (Regimen U), and for afatinib, TMZ, and RT (Regimen M).
Outcome measures
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=17 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=9 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Afatinib
|
30 Milligram (mg)
|
40 Milligram (mg)
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeksPopulation: Treated Set
Incidence and intensity of adverse events (AE) according to Common Terminology Criteria of Adverse Events (CTCAE v.3.0). The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Outcome measures
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 Participants
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)
Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)
Grade 2
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)
Grade 3
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)
Grade 4
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeksPopulation: Treated Set
Objective response was defined as a best overall response of complete response (CR) or partial response (PR). The best overall response was the best overall response to trial medication according to the Macdonald criteria recorded since the first administration of trial medication and until the earliest of disease progression, death, or start of further anti-cancer treatment. Tumour response was assessed based on local radiological image evaluation by the investigators according to the Macdonald criteria: Complete Response (CR): Disappearance of all enhancing tumour on consecutive Magnetic resonance imaging (MRI) scans at least 28 days apart, off steroids, and neurologically stable or improved. Partial Response (PR): At least 50% reduction in size of enhancing tumour on consecutive MRI scans at least 28 days apart, steroids stable or reduced, and neurologically stable or improved.
Outcome measures
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 Participants
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
The Objective Tumour Response According to the Macdonald Criteria
Yes
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Objective Tumour Response According to the Macdonald Criteria
Missing
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
The Objective Tumour Response According to the Macdonald Criteria
No
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic blood sample were taken at 5 minutes before drug on days 8, 15 and 29 and 1, 3 and 6 hours after drug administration on day 15Population: Treated Set; only evaluable patients were included in the pharmacokinetic analysis
Concentration of afatinib in plasma at steady state pre-dose (Cpre,ss) on days 8, 15 and 29.
Outcome measures
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 Participants
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 Participants
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 Participants
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|
|
Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29
Cpre, ss, 8
|
4.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.2
|
10.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 70.3
|
15.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32.8
|
4.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32.9
|
16.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.2
|
|
Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29
Cpre, ss, 15
|
5.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 55.1
|
9.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54.3
|
16.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 59.5
|
4.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 177.0
|
18.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.5
|
|
Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29
Cpre, ss, 29
|
5.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 92.0
|
17.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15.6
|
17.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.1
|
5.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 53.3
|
16.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.7
|
Adverse Events
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Total - Regimen M
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Afatinib 20 mg, Radiotherapy - Regimen U
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Afatinib 40 mg, Radiotherapy - Regimen U
Serious events: 10 serious events
Other events: 13 other events
Deaths: 3 deaths
Total - Regimen U
Serious events: 12 serious events
Other events: 16 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 participants at risk
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 participants at risk
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 participants at risk
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Total - Regimen M
n=20 participants at risk
Patients were administered Afatinib 20/30/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 participants at risk
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 participants at risk
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Total - Regimen U
n=16 participants at risk
Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Disease progression
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Malaise
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Pyrexia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Ataxia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Hemiparesis
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
23.1%
3/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
Other adverse events
| Measure |
Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M
n=7 participants at risk
Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M
n=6 participants at risk
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M
n=7 participants at risk
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Total - Regimen M
n=20 participants at risk
Patients were administered Afatinib 20/30/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
|
Afatinib 20 mg, Radiotherapy - Regimen U
n=3 participants at risk
Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Afatinib 40 mg, Radiotherapy - Regimen U
n=13 participants at risk
Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
Total - Regimen U
n=16 participants at risk
Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Psychiatric disorders
Mood altered
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Psychiatric disorders
Personality change
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Renal and urinary disorders
Bladder pain
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Renal and urinary disorders
Dysuria
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Renal and urinary disorders
Incontinence
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Reproductive system and breast disorders
Orchitis noninfective
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Reproductive system and breast disorders
Perineal erythema
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
23.1%
3/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.1%
4/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
35.0%
7/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Ear and labyrinth disorders
Deafness
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Asthenopia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Diplopia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Eye pain
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.0%
6/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
7/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
83.3%
5/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
71.4%
5/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
85.0%
17/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
100.0%
3/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
84.6%
11/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
87.5%
14/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
66.7%
4/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
71.4%
5/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
75.0%
15/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
57.1%
4/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
45.0%
9/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Asthenia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Facial pain
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Fatigue
|
71.4%
5/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
66.7%
4/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
55.0%
11/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
100.0%
3/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
46.2%
6/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
56.2%
9/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Feeling cold
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Mucosal inflammation
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Oedema
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Pain
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
General disorders
Unevaluable event
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Localised infection
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.8%
4/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
25.0%
4/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Nail infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
23.1%
3/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Paronychia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
23.1%
3/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
25.0%
4/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Rash pustular
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
50.0%
3/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.8%
4/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
25.0%
4/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Escherichia test positive
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Grip strength decreased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Lymphocyte count decreased
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
QRS axis abnormal
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
Weight decreased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Investigations
White blood cells urine
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
20.0%
4/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Diet refusal
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.8%
4/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
25.0%
4/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Ageusia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Aphasia
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Balance disorder
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Dysgeusia
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
2/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.0%
6/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
100.0%
3/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
53.8%
7/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
62.5%
10/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
30.8%
4/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
31.2%
5/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Memory impairment
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Neurological symptom
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Partial seizures
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Seizure
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.4%
2/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
18.8%
3/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Psychiatric disorders
Abnormal behaviour
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.1%
4/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
50.0%
3/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
50.0%
10/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
66.7%
2/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
46.2%
6/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
50.0%
8/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
12.5%
2/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
33.3%
1/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
71.4%
5/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
83.3%
5/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
42.9%
3/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
65.0%
13/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
66.7%
2/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
76.9%
10/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
75.0%
12/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
5.0%
1/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
28.6%
2/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
15.0%
3/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
16.7%
1/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
14.3%
1/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
10.0%
2/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/6 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/7 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/20 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
0.00%
0/3 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
7.7%
1/13 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
6.2%
1/16 • From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER