Trial Outcomes & Findings for Survival Prolongation by Rationale Innovative Genomics (NCT NCT03386929)
NCT ID: NCT03386929
Last Updated: 2023-12-18
Results Overview
The occurrence of adverse events and serious adverse events reported from the signing of an informed consent through 90 days after the last administration of the treatment will be summarized for all subjects who received at least one dose of the study treatment (safety population) and will be evaluated based on NCI CTCAE v4.03: June 14, 2010.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From informed consent signature through 90 days after administration of the treatment (last dose)
Results posted on
2023-12-18
Participant Flow
A total of 15 patients were recruited in the Phase 1 part of the study in 5 centers across 4 countries (Luxembourg, Israel, Spain and USA). The study was early terminated prior starting the Phase 2 due to lack of fundings. The following number of treated patients were initially planned to be recruited: up to 30 in the Phase 1 and 100 in the Phase 2.
Patients with advanced/metastatic advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (EGFR mutation, ALK translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) were recruited in the study.
Participant milestones
| Measure |
Dose Level 1
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (3 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 2
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 3
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (100 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
3
|
Reasons for withdrawal
| Measure |
Dose Level 1
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (3 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 2
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 3
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (100 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Progression
|
4
|
4
|
0
|
|
Overall Study
Clinical Monitoring Committee and physician choice
|
1
|
1
|
1
|
|
Overall Study
Transfer to SPRING Rollover protocol (EU CT # 2022-500041-24-00) after closing SPRING
|
1
|
0
|
0
|
Baseline Characteristics
Survival Prolongation by Rationale Innovative Genomics
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=6 Participants
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (3 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 2
n=6 Participants
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 3
n=3 Participants
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (100 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
54 years
n=5 Participants
|
67 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Luxembourg
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From informed consent signature through 90 days after administration of the treatment (last dose)Population: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
The occurrence of adverse events and serious adverse events reported from the signing of an informed consent through 90 days after the last administration of the treatment will be summarized for all subjects who received at least one dose of the study treatment (safety population) and will be evaluated based on NCI CTCAE v4.03: June 14, 2010.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to approximately 24 monthsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
Response rate is defined as the proportion of participants with reduction in tumor burden of a predefined amount based on RECIST 1.1 evaluation
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to approximately 24 monthsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
Duration of Response (DR) is defined for patients with confirmed objective response (Complete Response \[CR\] or Partial Response \[PR\]) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to approximately 24 monthsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to approximately 24 monthsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
OS is defined as the time from the first dose of study treatment to the date of death due to any cause.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 yearsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
The proportion of participants whose SIMS analysis matches the treatment combination, will be correlated retrospectively to clinical outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
The occurrence of treatment-related and or biopsy-related serious adverse events as assessed by NCI CTCAE v4.03 will be summarized for all study subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.
Genomic (DNA) and transcriptomic (RNA) aberrations (mutations, translocations, rearrangements and changes in expression level) identified in the study population (Non-Small Cell Lung) will be described.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Level 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=6 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (3 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 2
n=6 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 3
n=3 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (100 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Disease progression
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
Other adverse events
| Measure |
Dose Level 1
n=6 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (3 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 2
n=6 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (75 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
Dose Level 3
n=3 participants at risk
Non-small cell lung cancer (NSCLC) patients treated with avelumab (10 mg/kg IV every two weeks -1/+3 days, on day 1 and day 15 of a 28 day cycle), axitinib (5 mg taken orally twice a day, every day of a 28 day cycle) and palbociclib (100 mg taken orally, daily on days 8-28 of a 28 day cycle).
|
|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Eye disorders
Uveitis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 9 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 5 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Pain
|
66.7%
4/6 • Number of events 11 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
General disorders
Temperature regulation disorder
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Genital infection fungal
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Otitis media
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Infections and infestations
Urinary Tract infection
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
83.3%
5/6 • Number of events 13 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood cholesterol increased
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood potassium increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Gamma-Glutamyltransferase increased
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 10 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6 • Number of events 28 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 8 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 7 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
66.7%
4/6 • Number of events 14 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
Weight decreased
|
66.7%
4/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Investigations
White blood cell count decreased
|
66.7%
4/6 • Number of events 13 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 7 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
66.7%
4/6 • Number of events 9 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 12 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
3/6 • Number of events 5 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 5 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
66.7%
2/3 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Facial paralysis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
16.7%
1/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
83.3%
5/6 • Number of events 12 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 5 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Number of events 6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
66.7%
4/6 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
100.0%
3/3 • Number of events 4 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
3/6 • Number of events 5 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
33.3%
1/3 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Scab
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Embolism
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Number of events 6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
66.7%
4/6 • Number of events 11 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
100.0%
3/3 • Number of events 3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Number of events 2 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Superficial vein thrombosis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
|
Vascular disorders
Thrombosis
|
16.7%
1/6 • Number of events 1 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/6 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
0.00%
0/3 • From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.
AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Causal relationship between study treatment and AEs was determined by the investigators and the clinical monitoring committee, and events were considered drug-related if classified by the investigator as at least possibly related to study treatment.
|
Additional Information
Fanny Wunder, Project Manager
Worldwide Innovative Network (WIN) Association
Phone: 0033604090029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60