Trial Outcomes & Findings for Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib (NCT NCT00993499)
NCT ID: NCT00993499
Last Updated: 2015-10-07
Results Overview
Number of participants with of dose limiting toxicities (DLT)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
2 first cycles, 56 days
Results posted on
2015-10-07
Participant Flow
Participant milestones
| Measure |
Afa30+Sir01
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Run-in Period (8 Days)
STARTED
|
13
|
12
|
10
|
3
|
3
|
3
|
|
Run-in Period (8 Days)
COMPLETED
|
12
|
9
|
9
|
3
|
3
|
3
|
|
Run-in Period (8 Days)
NOT COMPLETED
|
1
|
3
|
1
|
0
|
0
|
0
|
|
Discontinued Before Starting Course 3
STARTED
|
12
|
9
|
9
|
3
|
3
|
3
|
|
Discontinued Before Starting Course 3
COMPLETED
|
8
|
5
|
6
|
2
|
3
|
3
|
|
Discontinued Before Starting Course 3
NOT COMPLETED
|
4
|
4
|
3
|
1
|
0
|
0
|
|
Discontinued After Starting Course 3
STARTED
|
12
|
9
|
9
|
3
|
3
|
3
|
|
Discontinued After Starting Course 3
COMPLETED
|
4
|
4
|
3
|
1
|
0
|
0
|
|
Discontinued After Starting Course 3
NOT COMPLETED
|
8
|
5
|
6
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Afa30+Sir01
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Run-in Period (8 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Period (8 Days)
Inclusion/exclusion criteria not met
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Run-in Period (8 Days)
Consent withdrawn
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Period (8 Days)
Progressive disease
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Discontinued Before Starting Course 3
Progressive Disease
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Discontinued Before Starting Course 3
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Discontinued Before Starting Course 3
Dose Limiting Toxicity (DLT)
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Discontinued Before Starting Course 3
Non compliance with the protocol
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Discontinued After Starting Course 3
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Discontinued After Starting Course 3
Progressive Disease
|
6
|
4
|
3
|
1
|
3
|
3
|
|
Discontinued After Starting Course 3
DLT
|
1
|
0
|
2
|
1
|
0
|
0
|
|
Discontinued After Starting Course 3
Other adverse event
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
Baseline characteristics by cohort
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
53.4 Years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
56.5 Years
STANDARD_DEVIATION 17.2 • n=8 Participants
|
58.9 Years
STANDARD_DEVIATION 12.3 • n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 first cycles, 56 daysPopulation: Treated set
Number of participants with of dose limiting toxicities (DLT)
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Occurrence of Dose Limiting Toxicities (DLT)
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Best overall response (unconfirmed) according to RECIST v1.1
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Best Overall Response
Complete Response
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Best Overall Response
Partial Response
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Best Overall Response
Stable Disease
|
50.0 Percentage of participants
|
44.4 Percentage of participants
|
44.4 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
|
Best Overall Response
Progressive Disease
|
33.3 Percentage of participants
|
22.2 Percentage of participants
|
11.1 Percentage of participants
|
33.3 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Best Overall Response
Not evaluable
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Best Overall Response
Missing (baseline data only)
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Objective Response
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Rate of Disease Control
|
58.3 Percentage of participants
|
44.4 Percentage of participants
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Multiple time points during the trialPopulation: Treated set. This endpoint was not analysed in the study report as the available data was too limited.
Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA. This endpoint was not analysed in the study report as the available data was too limited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinibPopulation: Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.
Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)
Outcome measures
| Measure |
Afa30+Sir01
n=7 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=6 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)
|
41.4 ng/mL
Geometric Coefficient of Variation 17.6
|
47.1 ng/mL
Geometric Coefficient of Variation 63.8
|
98.1 ng/mL
Geometric Coefficient of Variation 33.9
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
—
|
SECONDARY outcome
Timeframe: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinibPopulation: Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.
Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.
Outcome measures
| Measure |
Afa30+Sir01
n=6 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=4 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=1 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)
|
603 ng*h/mL
Geometric Coefficient of Variation 37.3
|
536 ng*h/mL
Geometric Coefficient of Variation 40.1
|
1560 ng*h/mL
Geometric Coefficient of Variation 49.6
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
1760 ng*h/mL
Geometric Coefficient of Variation NA
Not calculable as only one patient with data.
|
—
|
SECONDARY outcome
Timeframe: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinibPopulation: PK set
Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)
Outcome measures
| Measure |
Afa30+Sir01
n=8 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=5 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=7 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)
Sirolimus alone (N=8, 5, 7, 1, 2, 3)
|
7.96 ng/mL
Geometric Coefficient of Variation 40.7
|
13.8 ng/mL
Geometric Coefficient of Variation 24.1
|
32.5 ng/mL
Geometric Coefficient of Variation 43.8
|
30.2 ng/mL
Geometric Coefficient of Variation NA
Not calculable as only one patient with data.
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
28.5 ng/mL
Geometric Coefficient of Variation 21.9
|
|
Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)
Sirolimus with Afatinib (N=6, 3, 2, 2, 1, 0)
|
5.81 ng/mL
Geometric Coefficient of Variation 64.6
|
15.3 ng/mL
Geometric Coefficient of Variation 1.31
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
8.53 ng/mL
Geometric Coefficient of Variation NA
Not calculable as only one patient with data.
|
NA ng/mL
Geometric Coefficient of Variation NA
No patients with analyzable data
|
SECONDARY outcome
Timeframe: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinibPopulation: PK set
Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.
Outcome measures
| Measure |
Afa30+Sir01
n=6 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=4 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=7 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=2 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)
Sirolimus with Afatinib (N=4, 3, 2, 2, 1, 0)
|
106 ng*h/mL
Geometric Coefficient of Variation 57.9
|
207 ng*h/mL
Geometric Coefficient of Variation 24.4
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
141 ng*h/mL
Geometric Coefficient of Variation NA
Not calculable as only one patient with data.
|
NA ng*h/mL
Geometric Coefficient of Variation NA
No patients with analyzable data
|
|
AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)
Sirolimus alone (N=6, 4, 7, 1, 2, 2)
|
91.5 ng*h/mL
Geometric Coefficient of Variation 28.1
|
193 ng*h/mL
Geometric Coefficient of Variation 35.4
|
502 ng*h/mL
Geometric Coefficient of Variation 51.7
|
497 ng*h/mL
Geometric Coefficient of Variation NA
Not calculable as only one patient with data.
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
NA ng*h/mL
Geometric Coefficient of Variation NA
Not calculated as only 2 patients had data therefore a reliable estimate cannot be obtained.
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Occurrence of Adverse Events According to CTCAE, Version 3.0
Grade 1
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Occurrence of Adverse Events According to CTCAE, Version 3.0
Grade 2
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Occurrence of Adverse Events According to CTCAE, Version 3.0
Grade 3
|
58.3 Percentage of participants
|
55.6 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Occurrence of Adverse Events According to CTCAE, Version 3.0
Grade 4
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Occurrence of Adverse Events According to CTCAE, Version 3.0
Grade 5
|
8.3 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Percentage of patients with drug-related adverse events (AEs).
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Drug-related AEs
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 daysPopulation: Treated set
Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy's law cases.
Outcome measures
| Measure |
Afa30+Sir01
n=12 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 Participants
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
High total bilirubin
|
8.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
High AST (Aspartate aminotransferase)
|
16.7 Percentage of participants
|
11.1 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
High ALT (Alanine aminotransferase)
|
16.7 Percentage of participants
|
11.1 Percentage of participants
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
High alkaline phosphatase
|
9.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Afa30+Sir01
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Afa30+Sir03
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Afa30+Sir05
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Afa30+Sir10
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Afa40+Sir01
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Afa40+Sir05
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afa30+Sir01
n=12 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Asthenia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Hepatobiliary disorders
Hepatic failure
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Hepatic encephalopathy
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
Other adverse events
| Measure |
Afa30+Sir01
n=12 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa30+Sir03
n=9 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
|
Afa30+Sir05
n=9 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
|
Afa30+Sir10
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
|
Afa40+Sir01
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
|
Afa40+Sir05
n=3 participants at risk
Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Blood and lymphatic system disorders
Neutrophilia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Eye disorders
Ocular icterus
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Eye disorders
Trichomegaly
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
12/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
77.8%
7/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
77.8%
7/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Gingival pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
55.6%
5/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Odynophagia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Tooth discolouration
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
44.4%
4/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Asthenia
|
58.3%
7/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
44.4%
4/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Chest pain
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Facial pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Mucosal inflammation
|
41.7%
5/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
6/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
44.4%
4/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Oedema
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Pyrexia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
General disorders
Xerosis
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Conjunctivitis
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Ear infection
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Folliculitis
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Oral infection
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Paronychia
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Periumbilical abscess
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Injury, poisoning and procedural complications
Hand fracture
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Amylase increased
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Blood triglycerides increased
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Ejection fraction abnormal
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Lipase increased
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
4/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
44.4%
4/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
22.2%
2/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Alexia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Aphasia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Ataxia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Dysaesthesia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Sciatica
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Leukocyturia
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Renal and urinary disorders
Renal failure
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Reproductive system and breast disorders
Breast pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
100.0%
3/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
3/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
16.7%
2/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
6/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
55.6%
5/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
44.4%
4/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
66.7%
2/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
3/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
33.3%
1/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
11.1%
1/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
8.3%
1/12 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/9 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
0.00%
0/3 • From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
|
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