Trial Outcomes & Findings for A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations (NCT NCT01647711)
NCT ID: NCT01647711
Last Updated: 2017-01-31
Results Overview
Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
28 days
Results posted on
2017-01-31
Participant Flow
Afatinib was administered until disease progression, however patients experiencing clinical benefit were allowed to continue treatment for as long as judged beneficial by the investigator.
Participant milestones
| Measure |
Afatinib 90mg
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
9
|
11
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
9
|
11
|
6
|
Reasons for withdrawal
| Measure |
Afatinib 90mg
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
6
|
2
|
6
|
8
|
2
|
|
Overall Study
Other adverse event
|
0
|
0
|
2
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Refused to continue taking medication
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Other reason not defined
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
Baseline characteristics by cohort
| Measure |
Afatinib 90mg
n=6 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
n=3 Participants
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=9 Participants
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=11 Participants
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=6 Participants
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.0 Years
n=5 Participants
|
58.0 Years
n=7 Participants
|
65.0 Years
n=5 Participants
|
61.0 Years
n=4 Participants
|
62.5 Years
n=21 Participants
|
64.0 Years
n=10 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated set including patients eligible for MTD determination
Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
Outcome measures
| Measure |
Afatinib 90mg
n=6 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
n=3 Participants
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=7 Participants
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=9 Participants
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=5 Participants
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Dose Limiting Toxicities
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
40.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated set including patients eligible for MTD determination
Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).
Outcome measures
| Measure |
Afatinib 90mg
n=30 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose
|
160 mg
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug administration until last drug administration, up to 420 daysPopulation: Treated set including participants with EGFR T790M positive mutations
Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
Outcome measures
| Measure |
Afatinib 90mg
n=1 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=7 Participants
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=1 Participants
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=4 Participants
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Objective Response Rate for Patients With EGFR T790M Mutations
|
0.0 Percentage of participants
|
—
|
14.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)Population: Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.
Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A
Outcome measures
| Measure |
Afatinib 90mg
n=6 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
n=3 Participants
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=8 Participants
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=8 Participants
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=5 Participants
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Cmax of Afatinib on Day 3 of Course 1
|
129 ng/mL
Geometric Coefficient of Variation 46.2
|
155 ng/mL
Geometric Coefficient of Variation 86.9
|
311 ng/mL
Geometric Coefficient of Variation 58.8
|
313 ng/mL
Geometric Coefficient of Variation 35.6
|
461 ng/mL
Geometric Coefficient of Variation 50.3
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Treated set including patients eligible for MTD determination
Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.
Outcome measures
| Measure |
Afatinib 90mg
n=30 Participants
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
|---|---|---|---|---|---|
|
Determination of Dosage for Expansion Cohort in Part B
|
150 mg
|
—
|
—
|
—
|
—
|
Adverse Events
Afatinib 90mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Afatinib 120mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Afatinib 150mg
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Afatinib 160mg
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Afatinib 200mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
All Participants
Serious events: 14 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 90mg
n=6 participants at risk
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
n=3 participants at risk
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=9 participants at risk
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=11 participants at risk
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=6 participants at risk
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
All Participants
n=35 participants at risk
All treated participants included in the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Urosepsis
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
Other adverse events
| Measure |
Afatinib 90mg
n=6 participants at risk
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 120mg
n=3 participants at risk
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 150mg
n=9 participants at risk
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 160mg
n=11 participants at risk
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
Afatinib 200mg
n=6 participants at risk
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
|
All Participants
n=35 participants at risk
All treated participants included in the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Proctalgia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
3/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
45.5%
5/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
66.7%
4/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
37.1%
13/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Catheter site ulcer
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Chills
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Fatigue
|
50.0%
3/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
55.6%
5/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
63.6%
7/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
51.4%
18/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
63.6%
7/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
25.7%
9/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
14.3%
5/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Candida infection
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Clostridium difficile infection
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Enterobacter bacteraemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Escherichia bacteraemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Skin candida
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
27.3%
3/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
17.1%
6/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Eye disorders
Blindness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Aphthous ulcer
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
27.3%
3/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
14.3%
5/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
66.7%
2/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
77.8%
7/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
100.0%
11/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
100.0%
6/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
88.6%
31/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
44.4%
4/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
14.3%
5/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Eructation
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
55.6%
5/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
45.5%
5/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
66.7%
4/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
45.7%
16/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Oral discomfort
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
27.3%
3/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
Weight decreased
|
50.0%
3/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
3/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
25.7%
9/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
44.4%
4/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
36.4%
4/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
50.0%
3/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
34.3%
12/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.4%
4/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
14.3%
5/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Restless legs syndrome
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Reproductive system and breast disorders
Vulval haemorrhage
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
8.6%
3/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
2/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
22.2%
2/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
18.2%
2/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
17.1%
6/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
3/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
27.3%
3/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
20.0%
7/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Nail bed tenderness
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
1/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
4/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
66.7%
2/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
33.3%
3/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
36.4%
4/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
66.7%
4/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
48.6%
17/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
11.1%
1/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
2.9%
1/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/3 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/9 • From first treatment administration until 28 days after the last administration, up to 448 days
|
9.1%
1/11 • From first treatment administration until 28 days after the last administration, up to 448 days
|
0.00%
0/6 • From first treatment administration until 28 days after the last administration, up to 448 days
|
5.7%
2/35 • From first treatment administration until 28 days after the last administration, up to 448 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER