Trial Outcomes & Findings for A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel (NCT NCT01251653)
NCT ID: NCT01251653
Last Updated: 2016-05-30
Results Overview
DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever \>38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever \>38.5º C or Grade ≥3 infection. 3. Platelet count of \<25x 10\^9/L or \<50x 10\^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
Recruitment status
COMPLETED
Target enrollment
94 participants
Primary outcome timeframe
3 weeks
Results posted on
2016-05-30
Participant Flow
All patients were completed the study but discontinued from the trial medication
This was an uncontrolled, open-label, Phase I, '3+3' dose-escalation trial to determine the maximum tolerated dose (MTDs) for combination Afatinib with Gemcitabine or with Docetaxel; 2 MTDs were to be defined, one for Afatinib with Gemcitabine (Cohort A) and one for Afatinib with Docetaxel (Cohort B).
Participant milestones
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
20
|
6
|
2
|
18
|
18
|
12
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
20
|
6
|
2
|
18
|
18
|
12
|
6
|
Reasons for withdrawal
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
7
|
16
|
4
|
0
|
17
|
14
|
7
|
5
|
|
Overall Study
Dose-limiting toxicity
|
0
|
1
|
1
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
1
|
1
|
0
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Other reason not mentioned above
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel
Baseline characteristics by cohort
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 20.8 • n=93 Participants
|
52.1 Years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
57.7 Years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
52.3 Years
STANDARD_DEVIATION 16.5 • n=483 Participants
|
61.0 Years
STANDARD_DEVIATION 1.4 • n=36 Participants
|
55.4 Years
STANDARD_DEVIATION 11.0 • n=10 Participants
|
59.2 Years
STANDARD_DEVIATION 10.6 • n=115 Participants
|
59.3 Years
STANDARD_DEVIATION 10.2 • n=40 Participants
|
54.5 Years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
56.7 Years
STANDARD_DEVIATION 11.2 • n=62 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
49 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
44 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Treated Set (TS)
DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever \>38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever \>38.5º C or Grade ≥3 infection. 3. Platelet count of \<25x 10\^9/L or \<50x 10\^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.Population: TS
The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
The Incidence and Intensity of AEs With Grading According to CTCAE.
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Incidence and Intensity of AEs With Grading According to CTCAE.
Grade 2
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Incidence and Intensity of AEs With Grading According to CTCAE.
Grade 3
|
0 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
The Incidence and Intensity of AEs With Grading According to CTCAE.
Grade 4
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
1 Participants
|
|
The Incidence and Intensity of AEs With Grading According to CTCAE.
Grade 5
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.Population: TS
Best overall response (according to Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response According to RECIST v1.1 Criteria
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response According to RECIST v1.1 Criteria
Partial response
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Best Overall Response According to RECIST v1.1 Criteria
Stable disease/ Non-CR/Non-PD
|
2 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Best Overall Response According to RECIST v1.1 Criteria
Progressive disease (PD)
|
1 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Best Overall Response According to RECIST v1.1 Criteria
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response According to RECIST v1.1 Criteria
Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.Population: TS
Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non-CR/non-PD for non-measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control According to RECIST v1.1
No
|
1 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Disease Control According to RECIST v1.1
Yes
|
2 Participants
|
4 Participants
|
13 Participants
|
5 Participants
|
0 Participants
|
10 Participants
|
13 Participants
|
9 Participants
|
2 Participants
|
|
Disease Control According to RECIST v1.1
Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.Population: TS
Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response According to RECIST v1.1
No
|
3 Participants
|
6 Participants
|
15 Participants
|
6 Participants
|
2 Participants
|
17 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
|
Objective Response According to RECIST v1.1
Yes
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Objective Response According to RECIST v1.1
Missing
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 12 weeks and 24 weeksPopulation: TS
Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Objective Response According to RECIST v1.1
6 Weeks
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Time to Objective Response According to RECIST v1.1
12 Weeks
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Time to Objective Response According to RECIST v1.1
24 Weeks
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Time to Objective Response According to RECIST v1.1
Not applicable
|
3 Participants
|
7 Participants
|
16 Participants
|
6 Participants
|
2 Participants
|
17 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the first documented complete response or partial response to the time of disease progression or deathPopulation: TS for patients who experienced objective response.
Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=1 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=4 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=1 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=5 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=4 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response According to RECIST v1.1
|
—
|
291.0 Days
Standard Deviation NA
Non Calculable as only one participant analysed.
|
138.3 Days
Standard Deviation 80.2
|
—
|
—
|
410.0 Days
Standard Deviation NA
Non Calculable as only one participant analysed.
|
296.0 Days
Standard Deviation 132.8
|
55.5 Days
Standard Deviation 64.4
|
—
|
SECONDARY outcome
Timeframe: From the first administration of study medication to the time of disease progression or deathPopulation: TS for patients who experienced disease control.
Duration of disease control according to RECIST v1.1.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=2 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=4 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=13 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=5 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=10 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
n=13 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=9 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=2 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Disease Control According to RECIST v1.1
|
119.5 Days
Standard Deviation 68.6
|
210.0 Days
Standard Deviation 118.1
|
119.7 Days
Standard Deviation 148.5
|
77.4 Days
Standard Deviation 19.9
|
—
|
207.1 Days
Standard Deviation 108.1
|
233.6 Days
Standard Deviation 150.8
|
158.7 Days
Standard Deviation 89.0
|
85.0 Days
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: From the first administration of study medication to the time of disease progression or deathPopulation: TS, MTD cohort
Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=18 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
23.9 Weeks
Inter-Quartile Range 148.5 • Interval 5.9 to 25.0
|
18.1 Weeks
Inter-Quartile Range 108.1 • Interval 5.7 to 31.3
|
23.6 Weeks
Inter-Quartile Range 150.8 • Interval 7.0 to 31.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first administration of study medication to the time of deathPopulation: TS, MTD cohort
Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=20 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=18 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=18 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
52.4 Weeks
Inter-Quartile Range 148.5 • Interval 35.4 to
Non calculable because the 75th percentile hasn't been reached
|
38.4 Weeks
Inter-Quartile Range 108.1 • Interval 26.0 to
Non calculable because the 75th percentile hasn't been reached
|
NA Weeks
Inter-Quartile Range 150.8 • Interval 68.1 to
Non calculable because the median hasn't been reached
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=8 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=5 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=12 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=14 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=10 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib
|
1000.0 ng*h/mL
Geometric Coefficient of Variation 24.5
|
1230.0 ng*h/mL
Geometric Coefficient of Variation 113.0
|
642.0 ng*h/mL
Geometric Coefficient of Variation 64.0
|
746.0 ng*h/mL
Geometric Coefficient of Variation 61.6
|
557.0 ng*h/mL
Geometric Coefficient of Variation 54.0
|
723.0 ng*h/mL
Geometric Coefficient of Variation 58.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Maximum concentration of Afatinib in plasma at steady state.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=9 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=6 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=14 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=13 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=15 Participants
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=10 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax,ss of Afatinib
|
58.1 ng/mL
Geometric Coefficient of Variation 73.3
|
66.4 ng/mL
Geometric Coefficient of Variation 106.0
|
33.9 ng/mL
Geometric Coefficient of Variation 70.2
|
45.6 ng/mL
Geometric Coefficient of Variation 78.7
|
33.9 ng/mL
Geometric Coefficient of Variation 50.6
|
45.7 ng/mL
Geometric Coefficient of Variation 68.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=11 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=13 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC 0-tz of Gemcitabine
|
9610.0 ng*h/mL
Geometric Coefficient of Variation 26.5
|
7120.0 ng*h/mL
Geometric Coefficient of Variation 38.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Maximum concentration of Gemcitabine in plasma.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=12 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=13 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Gemcitabine
|
16000.0 ng/mL
Geometric Coefficient of Variation 32.1
|
13500.0 ng/mL
Geometric Coefficient of Variation 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Total Clearance (CL) of Gemcitabine from plasma.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=11 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=13 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of Gemcitabine
|
3020.0 mL/min
Geometric Coefficient of Variation 35.7
|
4090.0 mL/min
Geometric Coefficient of Variation 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Apparent volume of distribution at steady state (Vss) of Gemcitabine.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=11 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=13 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of Gemcitabine
|
90.5 L
Geometric Coefficient of Variation 41.5
|
106.0 L
Geometric Coefficient of Variation 59.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=15 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=12 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=18 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=15 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC 0-24 of Docetaxel
|
2000.0 ng*h/mL
Geometric Coefficient of Variation 41.4
|
2210.0 ng*h/mL
Geometric Coefficient of Variation 41.7
|
2400.0 ng*h/mL
Geometric Coefficient of Variation 50.9
|
2270.0 ng*h/mL
Geometric Coefficient of Variation 46.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Maximum concentration of docetaxel in plasma.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=15 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=15 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=18 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=18 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Docetaxel
|
1690.0 ng/mL
Geometric Coefficient of Variation 42.8
|
1860.0 ng/mL
Geometric Coefficient of Variation 36.0
|
1790.0 ng/mL
Geometric Coefficient of Variation 61.7
|
2080.0 ng/mL
Geometric Coefficient of Variation 60.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Total Clearance (CL) of Docetaxel from plasma.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=14 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=12 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=14 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=15 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of Docetaxel
|
811.0 mL/min
Geometric Coefficient of Variation 38.0
|
671.0 mL/min
Geometric Coefficient of Variation 47.6
|
886.0 mL/min
Geometric Coefficient of Variation 34.7
|
892.0 mL/min
Geometric Coefficient of Variation 49.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55Population: The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.
Apparent volume of distribution at steady state (Vss) of Docetaxel.
Outcome measures
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=14 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=12 Participants
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=14 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=15 Participants
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
|
Afatinib 30mg and Docetaxel 75mg
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of Docetaxel
|
255.0 L
Geometric Coefficient of Variation 73.9
|
315.0 L
Geometric Coefficient of Variation 56.9
|
323.0 L
Geometric Coefficient of Variation 66.2
|
300.0 L
Geometric Coefficient of Variation 68.9
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Afatinib 30mg and Gemcitabine 1000mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Afatinib 30mg and Gemcitabine 1250mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Afatinib 40mg and Gemcitabine 1000mg
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Afatinib 40mg and Gemcitabine 1250mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Afatinib 50mg and Gemcitabine 1250mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Afatinib 30mg and Docetaxel 60mg
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Afatinib 30mg and Docetaxel 75mg
Serious events: 15 serious events
Other events: 18 other events
Deaths: 0 deaths
Afatinib 40mg and Docetaxel 75mg
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Afatinib 50mg and Docetaxel 75mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 participants at risk
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 75mg
n=18 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 participants at risk
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Sphingomonas paucimobilis infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
Other adverse events
| Measure |
Afatinib 30mg and Gemcitabine 1000mg
n=3 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Gemcitabine 1250mg
n=8 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1000mg
n=20 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 40mg and Gemcitabine 1250mg
n=6 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 50mg and Gemcitabine 1250mg
n=2 participants at risk
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 60mg
n=18 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 30mg and Docetaxel 75mg
n=18 participants at risk
Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 40mg and Docetaxel 75mg
n=12 participants at risk
Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
Afatinib 50mg and Docetaxel 75mg
n=6 participants at risk
Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
60.0%
12/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
2/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
38.9%
7/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
6/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
41.7%
5/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Mucocutaneous rash
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
60.0%
12/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
61.1%
11/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
35.0%
7/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
9/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
77.8%
14/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
58.3%
7/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Eyelid oedema
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Cheilitis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
30.0%
6/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
2/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
38.9%
7/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
87.5%
7/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
80.0%
16/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
83.3%
5/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
77.8%
14/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
94.4%
17/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
12/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
45.0%
9/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
83.3%
5/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
72.2%
13/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
72.2%
13/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
58.3%
7/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
10/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
55.6%
10/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
6/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Asthenia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
62.5%
5/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
70.0%
14/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
2/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
77.8%
14/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
61.1%
11/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
8/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
83.3%
5/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Chills
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
30.0%
6/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Injection site inflammation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Malaise
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Pyrexia
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
38.9%
7/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
General disorders
Ulcer
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Folliculitis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Genital herpes
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
45.0%
9/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
6/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Pleural infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Superinfection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Vulvitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Injury, poisoning and procedural complications
Face crushing
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Aortic bruit
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood iron decreased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Epidermal growth factor receptor decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
Weight decreased
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
40.0%
8/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
38.9%
7/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
4/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
10/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
2/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
9/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
44.4%
8/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
8/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
100.0%
2/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Ageusia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Aphonia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Nervous system disorders
Sciatica
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Penile erythema
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
30.0%
6/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
3/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
25.0%
5/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
6/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
2/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
4/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
4/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
40.0%
8/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
22.2%
4/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
44.4%
8/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
58.3%
7/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
2/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
62.5%
5/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
60.0%
12/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
66.7%
4/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
33.3%
6/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
72.2%
13/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
6/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
3/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
20.0%
4/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
1/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
27.8%
5/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
16.7%
3/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
10.0%
2/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
15.0%
3/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
50.0%
1/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.0%
1/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Arterial thrombosis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
11.1%
2/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/20 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/2 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
5.6%
1/18 • From first drug administration until 28 days after last drug administration, up to 717 days
|
8.3%
1/12 • From first drug administration until 28 days after last drug administration, up to 717 days
|
0.00%
0/6 • From first drug administration until 28 days after last drug administration, up to 717 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