Trial Outcomes & Findings for Ceritinib Rare Indications Study in ALK+ Tumors (NCT NCT02465528)
NCT ID: NCT02465528
Last Updated: 2019-12-27
Results Overview
The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline up to approximately 16 weeks
Results posted on
2019-12-27
Participant Flow
A minimum of 10 and a maximum of 20 subjects were to be enrolled in each arm (tumor type)
Participant milestones
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
12
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
12
|
5
|
Reasons for withdrawal
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Overall Study
Progressive disease
|
0
|
2
|
9
|
4
|
|
Overall Study
Study terminated by sponsor
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Ceritinib Rare Indications Study in ALK+ Tumors
Baseline characteristics by cohort
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=4 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
n=5 Participants
|
42.8 years
STANDARD_DEVIATION 19.41 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 15.40 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 14.64 • n=4 Participants
|
49.3 years
STANDARD_DEVIATION 15.85 • n=21 Participants
|
|
Age, Customized
18 to <65
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Customized
65 to <=75
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
2 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 16 weeksThe DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=4 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
|
100.00 percentage of participants
Interval 2.5 to 100.0
|
75.00 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeksORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=4 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator Assessment
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeksDOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=3 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Duration of Response (DOR) Per Investigator Assessment
|
NA weeks
Median was not reached for DOR therefore Confidence Interval was not estimable
|
NA weeks
Interval 3.0 to
Median was not reached for DOR
|
NA weeks
No participants experienced CR or PR for this cohort
|
NA weeks
No participants experienced CR or PR for this cohort
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeksTTR is defined as the time from date of the first dose to date of first documented response (CR or PR)
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=4 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Time to Response (TTR) Per Investigator Assessment
|
7.1 weeks
Confidence Interval was not estimable
|
16.4 weeks
Interval 6.3 to
Upper Confidence Interval was not estimable
|
NA weeks
No participants experienced CR or PR for this cohort
|
NA weeks
No participants experienced CR or PR for this cohort
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeksPopulation: no participants met definition of PFS
PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=2 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=9 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) Per Investigator Assessments
|
—
|
NA weeks
Interval 3.7 to
Median and upper CI were not estimable
|
1.7 weeks
Interval 1.1 to 2.7
|
1.7 weeks
Interval 1.6 to 5.1
|
SECONDARY outcome
Timeframe: Baseline up to approximately 84 weeksPopulation: There were no deaths in the ALCL and IMT arms
Deaths due to any cause during treatment and 30 day follow-up
Outcome measures
| Measure |
Anaplastic Large Cell Lymphoma (ALCL)
n=1 Participants
Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
|
Inflammatory Myofibroblastic Tumor (IMT)
n=4 Participants
Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
|
Glioblastoma (GBM)
n=12 Participants
Patients with GBM with a translocation involving the ALK gene
|
Any Other ALK-positive Tumor
n=5 Participants
Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
|
|---|---|---|---|---|
|
Percent of Participant Deaths During Treatment and Follow-up
|
0.0 percent of participants
|
0.0 percent of participants
|
25.0 percent of participants
|
20.0 percent of participants
|
Adverse Events
Anaplastic Large Cell Lymphoma
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inflammatory Myofibroblastic Tumor
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Glioblastoma
Serious events: 10 serious events
Other events: 12 other events
Deaths: 3 deaths
Any Other ALK+ Tumor
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
All Subjects
Serious events: 16 serious events
Other events: 22 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Anaplastic Large Cell Lymphoma
n=1 participants at risk
Anaplastic Large Cell Lymphoma
|
Inflammatory Myofibroblastic Tumor
n=4 participants at risk
Inflammatory Myofibroblastic Tumor
|
Glioblastoma
n=12 participants at risk
Glioblastoma
|
Any Other ALK+ Tumor
n=5 participants at risk
Any other ALK+ tumor
|
All Subjects
n=22 participants at risk
All Subjects
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
40.0%
2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
40.0%
2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
18.2%
4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Transaminases increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Paraneoplastic pemphigus
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
Other adverse events
| Measure |
Anaplastic Large Cell Lymphoma
n=1 participants at risk
Anaplastic Large Cell Lymphoma
|
Inflammatory Myofibroblastic Tumor
n=4 participants at risk
Inflammatory Myofibroblastic Tumor
|
Glioblastoma
n=12 participants at risk
Glioblastoma
|
Any Other ALK+ Tumor
n=5 participants at risk
Any other ALK+ tumor
|
All Subjects
n=22 participants at risk
All Subjects
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
60.0%
3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
22.7%
5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
40.0%
2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
22.7%
5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
40.0%
2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
22.7%
5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
18.2%
4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
75.0%
3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
58.3%
7/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
40.0%
2/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
59.1%
13/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
75.0%
3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
6/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
60.0%
3/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
59.1%
13/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
80.0%
4/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
11/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
80.0%
4/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
22.7%
5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
41.7%
5/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
27.3%
6/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Oedema
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Candiduria
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Genital herpes
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Infections and infestations
Uterine infection
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
75.0%
3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
31.8%
7/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
75.0%
3/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
22.7%
5/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
18.2%
4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
18.2%
4/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
50.0%
2/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
9.1%
2/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
13.6%
3/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
4.5%
1/22 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks
Any sign or symptom that occured during the study treatment plus 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER