Trial Outcomes & Findings for Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (NCT NCT01784068)
NCT ID: NCT01784068
Last Updated: 2025-09-10
Results Overview
Primary endpoint was the percentage of participants who were in MMR at 48 weeks after starting the TFR phase and is calculated by dividing the number of patients with MMR at 48 weeks after starting the TFR phase with no loss of MMR and no re-initiation of nilotinib therapy in the first 48 weeks after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment were considered as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
48 weeks
Results posted on
2025-09-10
Participant Flow
215 patients were actually enrolled in the NTCS (nilotinib treatment consolidation) phase. 190 of the 215 patients completed 52 weeks of nilotinib treatment in the NTCS phase and entered the treatment-free remission (TFR) phase.
Approximately 175 patients were planned to be enrolled into the study.
Participant milestones
| Measure |
NTCS Phase
Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
|
TFR Phase
Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
|
|---|---|---|
|
NTCS Phase
STARTED
|
215
|
0
|
|
NTCS Phase
NTRI Phase
|
86
|
0
|
|
NTCS Phase
NTCT Phase
|
13
|
0
|
|
NTCS Phase
TFR-2 Phase
|
8
|
0
|
|
NTCS Phase
NTCT-P Phase
|
2
|
0
|
|
NTCS Phase
NTRI-2
|
0
|
0
|
|
NTCS Phase
COMPLETED
|
0
|
0
|
|
NTCS Phase
NOT COMPLETED
|
215
|
0
|
|
TFR Phase
STARTED
|
0
|
190
|
|
TFR Phase
COMPLETED
|
0
|
97
|
|
TFR Phase
NOT COMPLETED
|
0
|
93
|
Reasons for withdrawal
| Measure |
NTCS Phase
Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
|
TFR Phase
Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
|
|---|---|---|
|
NTCS Phase
Adverse Event
|
5
|
0
|
|
NTCS Phase
Physician Decision
|
2
|
0
|
|
NTCS Phase
Patient/guardian decision
|
3
|
0
|
|
NTCS Phase
Death
|
2
|
0
|
|
NTCS Phase
Completed phase = discontinuation of study except for TFR and TFR2 phases
|
203
|
0
|
|
TFR Phase
Physician Decision
|
0
|
1
|
|
TFR Phase
Patient/guardian decision
|
0
|
3
|
|
TFR Phase
Death
|
0
|
1
|
|
TFR Phase
Lack of Efficacy
|
0
|
88
|
Baseline Characteristics
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
Baseline characteristics by cohort
| Measure |
NTCS Phase
n=215 Participants
Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
|
|---|---|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
189 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: FAS: The FAS included the 190 patients who completed 52 weeks of nilotinib treatment in the NTCS phase and entered TFR phase
Primary endpoint was the percentage of participants who were in MMR at 48 weeks after starting the TFR phase and is calculated by dividing the number of patients with MMR at 48 weeks after starting the TFR phase with no loss of MMR and no re-initiation of nilotinib therapy in the first 48 weeks after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment were considered as non-responders.
Outcome measures
| Measure |
TFR Phase
n=190 Participants
Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
|
|---|---|
|
Percentage of Patients Who Are in MMR (Major Molecular Response) at 48 Weeks After Starting the Treatment-free Remission (TFR) Phase
|
51.6 Percentage of participants
Interval 44.2 to 58.9
|
SECONDARY outcome
Timeframe: 48 weeksProportion of patients who are in MR4.5 at 48 weeks after starting the TFR phase is calculated by dividing the number of patients with MR4.5 at 48 weeks after starting the TFR phase with no loss of MR4.5 and no re-initiation of nilotinib therapy in the first 48 weeks after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment will be considered as non-responders. MR4.5 = log reductions of the BCR-ABR transcript load in blood as a measurement of deep molecular response of the CML clone to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 yearsProportion of patients who are in MMR at 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase is calculated by dividing the number of patients with MMR at 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase with no loss of MMR and no re-initiation of nilotinib therapy in the first 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment will be considered as non-responders
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 yearsProportion of patients who are in MR4.5 at 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase is calculated by dividing the number of patients with MR4.5 at 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase with no loss of MR4.5 and no re-initiation of nilotinib therapy in the first 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment will be considered as non-responders
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48, 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 yearsProportion of patients who are in MMR at 48, 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase is calculated by dividing the number of patients with MMR at 48, 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase by the number of patients who entered the TFR phase. Patients who are re-initiated with nilotinib but have less than 12 weeks of re-initiation of treatment will be excluded from the analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48, 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 yearsProportion of patients who are in MR4.5 at 48, 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase is calculated by dividing the number of patients with MR4.5 at 48, 96, 144, 192, 264 weeks and at the end of 6, 7, 8, 9 and 10 years after starting the TFR phase by the number of patients who entered the TFR phase. Patients who are re-initiated with nilotinib but have less than 12 weeks of re-initiation of treatment will be excluded from the analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksProportion of patients who achieve MMR within 12 weeks of re-initiation of nilotinib is calculated by dividing the number of patients who are in MMR at least at one assessment within 12 weeks after re-start of nilotinib treatment by the number of patients who are re-initiated for at least 12 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks up to week 24 and every 12 weeks thereafter up to 528 weeks after last patient has entered the TFRDescriptive statistics of BCR-ABL levels (IS) over time after re-start of nilotinib therapy up to 528 weks after the last patient has entered TFR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks up to week 24 and every 12 weeks thereafter up to 528 weeks after the last patient has entered TFRDefined as time from date of start of re-initiation of treatment after loss of MMR to the date of first achievement of MMR. Patients who do not regain MMR after re-initiation of treatment on or before the cut-off date, duration will be censored at the date of last PCR assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks up to week 24 and every 12 weeks thereafter up to 528 weeks after the last patient has entered TFRDefined as the time from start of re-initiation of treatment after loss of MMR to the first achievement of MR4.5. Patients who do not regain MR4.5 after re-initiation of treatment on or before the cut-off date, duration will be censored at the date of last PCR assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks in the first period of 48 weeks of the TFR, every 6 weeks in the second period of 48 weeks in TFR and every 12 weeks in the last period of 432 weeks of the TFRTFS is defined as the time from the start of the TFR phase to the earliest occurrence of loss of MMR, re-initiation of treatment due to any cause, progression of AP/BC or death due to any cause. For patients without any event on or before the cut-off date, survival time will be censored at the date of their last assessment (PCR, cytogenetic, hematologic or extramedullary). A TFS sensitivity analysis will be conducted to consider discontinuation from TFR phase due to any reason as a TFS event, in addition to the TFS events as defined above.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks in the first period of 48 weeks of the TFR, every 6 weeks in the second period of 48 weeks of TFR and every 12 weeks in the last period of 432 weeks of the TFRPFS is defined as the time from the start of the TFR phase to the earliest occurrence of progression to AP/BC or death due to any cause. For patients without any event on or before the cut-off date, survival time will be censored at the date of their last assessment (cytogenetic, hematologic or extramedullary) for patients who are still on study and at the date of last contact for patients who are in follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks in the first period of 48 weeks of the TFR, every 6 weeks in the second period of 48 weeks of TFR and every 12 weeks in the last period of 432 weeks of the TFROS is defined as the time from start of the TFR phase to death due to any cause. For patients without any event on or before the cut-off date, survival time will be censored at the date of their last assessment for patients who are still on study and at the date of last contact for patients who are in follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks in treatment consolidation and during the first 24 weeks of the re-initiation phase, every 12 weeks thereafter. Every 4, 6 and 12 weeks respectively in the first and second period of 48 weeks and in the last period of 432 weeks of the TFRSafety profile includes type, frequency and severity of adverse events, laboratory abnormalities and clinically notable ECG and other safety parameters during the nilotinib treatment consolidation phase, during the TFR phase and during re-initiation of treatment with nilotinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months in patients who lost MMR until the result is negative or up to 528 weeks after the last patient entered TFR. On average 3 analyses (every 3 months or up to 264 weeks after the last patient has entered TFR.)Proportion will be calculated by dividing the number of patients who developT315I, E255K/V, Y253H, F359V/C/I mutations after nilotinib suspension by the number of patients who lost MMR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48, 96, 144, 192, 240, 288, 336, 384 and 432 weeksProportion of patients who are in stable MMR/MR4.5 after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384 and 432 weeks, based on availability of appropriate data, is calculated by dividing the number of patients achieving MMR/MR4.5 any time during the nilotinib re-initiation phase and having the same response 48, 96, 144, 192, 240, 288, 336, 384 and 432 weeks after the first achievement of MMR/MR4.5, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR/MR4.5 at any time during the nilotinib re-initiation phase
Outcome measures
Outcome data not reported
Adverse Events
NTCS Phase
Serious events: 20 serious events
Other events: 136 other events
Deaths: 2 deaths
TFR Phase
Serious events: 15 serious events
Other events: 91 other events
Deaths: 1 deaths
NTRI Phase
Serious events: 11 serious events
Other events: 49 other events
Deaths: 2 deaths
NTCT Phase
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
TFR-2 Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NTRI-2 Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NTCT-P Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Patients
Serious events: 40 serious events
Other events: 171 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
NTCS Phase
n=215 participants at risk
Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
|
TFR Phase
n=190 participants at risk
Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
|
NTRI Phase
n=86 participants at risk
If at any time during TFR phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
|
NTCT Phase
n=13 participants at risk
Patients with no MRD at the end of consolidation phase entered the continuation phase of the study and continue with nilotinib 300 mg BID
|
TFR-2 Phase
n=8 participants at risk
Patients with MRD at the end of the continuation phase entered the TFR-2 phase of the study where no treatment was given
|
NTRI-2 Phase
If at any time during TFR phase or TFR-2 phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
|
NTCT-P Phase
n=2 participants at risk
Patients with no MRD at the end of continuation phase entered the prolonged continuation phase of the study
|
All Patients
n=215 participants at risk
All patients enrolled in the study
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
2/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
IRIS NEOVASCULARISATION
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
CHEST PAIN
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
DEATH
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
DACRYOCYSTITIS
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
HERPES ZOSTER
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
PHARYNGEAL ABSCESS
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER IN SITU
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
DIZZINESS
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
HEADACHE
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
SCIATICA
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
HAEMORRHAGE URINARY TRACT
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Other adverse events
| Measure |
NTCS Phase
n=215 participants at risk
Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID)
|
TFR Phase
n=190 participants at risk
Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given
|
NTRI Phase
n=86 participants at risk
If at any time during TFR phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
|
NTCT Phase
n=13 participants at risk
Patients with no MRD at the end of consolidation phase entered the continuation phase of the study and continue with nilotinib 300 mg BID
|
TFR-2 Phase
n=8 participants at risk
Patients with MRD at the end of the continuation phase entered the TFR-2 phase of the study where no treatment was given
|
NTRI-2 Phase
If at any time during TFR phase or TFR-2 phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID)
|
NTCT-P Phase
n=2 participants at risk
Patients with no MRD at the end of continuation phase entered the prolonged continuation phase of the study
|
All Patients
n=215 participants at risk
All patients enrolled in the study
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
FATIGUE
|
4.2%
9/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
6/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
4/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.4%
18/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.2%
9/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
6/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.0%
15/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.6%
12/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
9/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
2/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.2%
22/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
10/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
VOMITING
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
5/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
11/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
8/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
INFLUENZA
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.1%
4/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
2/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
11/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
LARYNGITIS
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.2%
22/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.9%
17/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.1%
7/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
36/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
PHARYNGITIS
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
9/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.4%
16/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
FALL
|
2.3%
5/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.1%
4/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
5/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.5%
14/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
LIPASE INCREASED
|
3.7%
8/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.1%
7/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.0%
15/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
3/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.1%
7/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
10/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
7.4%
16/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
5/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.9%
17/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.9%
17/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.1%
23/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
4/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.1%
39/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.2%
9/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
7/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.8%
19/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
9/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
2/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.0%
13/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.1%
4/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
4/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.5%
14/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
7/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.5%
14/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
9/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
1/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.0%
15/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.7%
8/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
13/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.2%
22/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
HEADACHE
|
4.2%
9/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
11/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.0%
6/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.2%
24/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
ANXIETY
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
3/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
DEPRESSION
|
1.4%
3/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
5/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.93%
2/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
10/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.47%
1/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.8%
6/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
1/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
8/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
9/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.3%
5/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.9%
4/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.1%
2/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.3%
8/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.0%
15/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.3%
7/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.53%
1/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.0%
13/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
HYPERTENSION
|
7.4%
16/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
7/190 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
3/86 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/8 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
—
0/0 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.2%
24/215 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 26 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER