Trial Outcomes & Findings for Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours (NCT NCT00716417)
NCT ID: NCT00716417
Last Updated: 2025-08-05
Results Overview
Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
21 days
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Pac175 + Cis50 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
5
|
11
|
1
|
3
|
7
|
3
|
5
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
5
|
11
|
1
|
3
|
7
|
3
|
5
|
3
|
Reasons for withdrawal
| Measure |
Pac175 + Cis50 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
1
|
0
|
0
|
3
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
3
|
5
|
3
|
8
|
0
|
3
|
3
|
1
|
5
|
0
|
|
Overall Study
Dose limiting toxicity (DLT)
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
On patient request due to toxicities
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=6 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=11 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
n=1 Participants
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=7 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=3 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=3 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION NA • n=21 Participants
|
52.7 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
53.1 years
STANDARD_DEVIATION 16.1 • n=115 Participants
|
65.0 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
59.2 years
STANDARD_DEVIATION 14.4 • n=42 Participants
|
63.7 years
STANDARD_DEVIATION 9.3 • n=42 Participants
|
58.58 years
STANDARD_DEVIATION 11.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.
Outcome measures
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=6 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=11 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
n=1 Participants
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=7 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=3 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=3 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.
Outcome measures
| Measure |
Pac175 + Cis50 + Afatinib20
n=26 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=21 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B
Maximum tolerated dose - Afatinib
|
20 mg/m^2
|
30 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B
Maximum tolerated dose - Cisplatin
|
75 mg/m^2
|
100 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B
Maximum tolerated dose - Pac (A) or 5-FU (B)
|
175 mg/m^2
|
750 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)Population: Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).
Outcome measures
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=6 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=11 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
n=1 Participants
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=7 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=3 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=5 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=3 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Objective Response
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administrationPopulation: The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.
Cmax,ss represents the maximum concentration of afatinib in plasma at steady state
Outcome measures
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=4 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=2 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=4 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 Participants
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=6 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=1 Participants
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=3 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=1 Participants
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)
|
22.1 ng/mL
Geometric Coefficient of Variation 22.5
|
18.0 ng/mL
Geometric Coefficient of Variation 24.9
|
17.7 ng/mL
Geometric Coefficient of Variation 13.2
|
32.1 ng/mL
Geometric Coefficient of Variation 79.2
|
—
|
48.9 ng/mL
Geometric Coefficient of Variation 26.0
|
57.0 ng/mL
Geometric Coefficient of Variation 41.1
|
32.7 ng/mL
Geometric Coefficient of Variation NA
Not calculable. If N= 1 individual values are displayed.
|
13.4 ng/mL
Geometric Coefficient of Variation 28.9
|
17.3 ng/mL
Geometric Coefficient of Variation NA
Not calculable. If N= 1 individual values are displayed.
|
Adverse Events
Pac175 + Cis50 + Afatinib20
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Pac175 + Cis75 + Afatinib20
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Pac175 + Cis75 + Afatinib30
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Pac175 + Cis75 + Afatinib40
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Pac175 + Cis75 + Afatinib50
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cis75 + 5FU750 + Afatinib20
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cis75 + 5FU750 + Afatinib30
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Cis75 + 5FU750 + Afatinib40
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cis100 + 5FU750 + Afatinib30
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cis100 + 5FU1000 + Afatinib30
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=6 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=5 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=11 participants at risk
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
n=1 participants at risk
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=7 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=3 participants at risk
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=5 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=3 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
36.4%
4/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Duodenal obstruction
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
42.9%
3/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Asthenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Fatigue
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Brain abscess
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Weight decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Renal failure
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
Other adverse events
| Measure |
Pac175 + Cis50 + Afatinib20
n=3 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 50mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib20
n=6 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib30
n=5 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib40
n=11 participants at risk
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Pac175 + Cis75 + Afatinib50
n=1 participants at risk
Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib20
n=3 participants at risk
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib30
n=7 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis75 + 5FU750 + Afatinib40
n=3 participants at risk
Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 75mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU750 + Afatinib30
n=5 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
Cis100 + 5FU1000 + Afatinib30
n=3 participants at risk
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m\^2 and Cisplatin 100mg/m\^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pyrexia
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
4/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
54.5%
6/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
42.9%
3/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
50.0%
3/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
54.5%
6/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Cardiac disorders
Conduction disorder
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Ear and labyrinth disorders
Deafness
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Cataract
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Eye swelling
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
36.4%
4/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
54.5%
6/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
71.4%
5/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Gastric ulcer
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Lip disorder
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
4/6 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
72.7%
8/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
71.4%
5/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
80.0%
4/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Asthenia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Chest pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Fatigue
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
90.9%
10/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
85.7%
6/7 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Feeling cold
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Localised oedema
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Oedema
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
General disorders
Pain
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Folliculitis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Fungal infection
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Omphalitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
1/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Electrocardiogram ST segment elevation
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
Weight decreased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
50.0%
3/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
36.4%
4/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
60.0%
3/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
42.9%
3/7 • First administration of trial medication until 28 days after last administration of trial medication
|
100.0%
3/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
54.5%
6/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Ageusia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
50.0%
3/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
36.4%
4/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Psychiatric disorders
Self esteem inflated
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Oliguria
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
42.9%
3/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
27.3%
3/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
28.6%
2/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
36.4%
4/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Nail pitting
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
2/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
45.5%
5/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
66.7%
2/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
18.2%
2/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
16.7%
1/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
20.0%
1/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
40.0%
2/5 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
9.1%
1/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
14.3%
1/7 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
|
Vascular disorders
Venous thrombosis limb
|
33.3%
1/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/6 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/11 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/1 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/7 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/5 • First administration of trial medication until 28 days after last administration of trial medication
|
0.00%
0/3 • First administration of trial medication until 28 days after last administration of trial medication
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication
- Publication restrictions are in place
Restriction type: OTHER