Trial Outcomes & Findings for Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) (NCT NCT01698905)
NCT ID: NCT01698905
Last Updated: 2025-09-02
Results Overview
TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
First 48 weeks following nilotinib cessation.
Results posted on
2025-09-02
Participant Flow
A total of 163 patients were enrolled into this study. 126 of the 163 patients who completed 52 weeks of nilotinib treatment in the NTCS phase entered the TFR phase and were part of the Full analysis Set (FAS).
Approximately 117 patients were planned to be enrolled into this study.
Participant milestones
| Measure |
NTCS Phase
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
|---|---|
|
Overall Study
STARTED
|
163
|
|
Overall Study
Still on Study Phase
|
0
|
|
Overall Study
TFR Phase
|
126
|
|
Overall Study
NTRI Phase
|
51
|
|
Overall Study
NTCT Phase
|
26
|
|
Overall Study
TFR-2 Phase
|
2
|
|
Overall Study
NTRI-2 Phase
|
1
|
|
Overall Study
NTCT-P Phase Phase
|
6
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
NTCS Phase
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Subject/guardian decision
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
Baseline characteristics by cohort
| Measure |
NTCS Phase
n=163 Participants
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
127 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 48 weeks following nilotinib cessation.Population: Full Analysis Set (FAS): FAS included all patients who entered the TFR phase.
TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.
Outcome measures
| Measure |
NTCS Phase
n=126 Participants
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
|---|---|
|
Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks
|
57.9 Percentage of participants
Interval 48.8 to 66.7
|
SECONDARY outcome
Timeframe: 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessationTFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, multiplied by 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: nilotinib cessation up to approximately 580 weeksKaplan-Meier (KM) estimation of PFS. PFS is measured from the date of start of nilotinib TFR phase (cessation of nilotinib) to the date of the earliest of the event: progression to AP/BC, or death from any cause. Patients not known to have recurred or died on or before the cut-off date for the KM analysis will have their PFS interval right-censored at the earlier of the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: nilotinib cessation up to approximately 580 weeksKaplan-Meier (KM) estimation of TFS is measured from the date of the start of the nilotinib TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4, re-start of nilotinib treatment, progression to AP/BC or death from any cause. Patients not known to have had any of the events or died on or before the cut-off date for the KM analysis will have their TFS interval right-censored at the earlier of the date of their last assessment (PCR, cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up. A TFS sensitivity analysis will be conducted by considering discontinuation from TFR phase due to any reason as an event, in addition to the events as defined above
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: nilotinib cessation up to approximately 580 weeksKaplan-Meier (KM) estimation of OS. OS is measured from the date of start of nilotinib TFR phase to the date of death from any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: re-start of nilotinib up to approximately 48 weeksDescriptive statistics of BCR-ABL over time after re-start of nilotinib therapy. ABL= Abelson leukemia virus and BCR=Break point cluster region
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: start of nilotinib in re-initiation phase up to approximately 432 weeksPercentage of patients who are in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MMR any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MMR, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR at any time during the nilotinib re-initiation phase, and multiplied by 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: start of nilotinib in re-initiation phase up to approximately 432 weeksPercentage of patients who are in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4, irrespective of whether there is loss of MR4 in between, by the number of patients who achieved MR4 at any time during the nilotinib re-initiation phase, and multiplied by 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: start of nilotinib in re-initiation phase up to approximately 432 weeksPercentage of patients who are in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4.5 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4.5, irrespective of whether there is loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the nilotinib re-initiation phase, multiplied by 100.
Outcome measures
Outcome data not reported
Adverse Events
NTCS Phase
Serious events: 21 serious events
Other events: 80 other events
Deaths: 1 deaths
TFR Phase
Serious events: 8 serious events
Other events: 70 other events
Deaths: 0 deaths
NTRI Phase
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
NTCT Phase
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
TFR-2 Phase
Serious events: 0 serious events
Other events: 0 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: 2 other events
Deaths: 0 deaths
All Patients
Serious events: 34 serious events
Other events: 122 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NTCS Phase
n=163 participants at risk
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
TFR Phase
n=126 participants at risk
treatment-free remission
|
NTRI Phase
n=51 participants at risk
nilotinib treatment re-initiation
|
NTCT Phase
n=26 participants at risk
nilotinib treatment continuation
|
TFR-2 Phase
n=2 participants at risk
treatment-free remission 2
|
NTRI-2 Phase
n=1 participants at risk
nilotinib treatment re-initiation 2
|
NTCT-P Phase
n=6 participants at risk
nilotinib treatment prolonged continuation
|
All Patients
n=163 participants at risk
All patients enrolled in the study
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
NECROSIS
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
CELLULITIS
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
DIVERTICULITIS
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
INFLUENZA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
PNEUMONIA
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
HAEMATOLOGY TEST ABNORMAL
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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)
ADENOCARCINOMA
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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)
LUNG ADENOCARCINOMA
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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)
LYMPHOPROLIFERATIVE DISORDER
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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)
PROSTATE CANCER
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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)
URETERIC CANCER
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL FIBROSIS
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
ARTERIAL HAEMORRHAGE
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Other adverse events
| Measure |
NTCS Phase
n=163 participants at risk
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
|
TFR Phase
n=126 participants at risk
treatment-free remission
|
NTRI Phase
n=51 participants at risk
nilotinib treatment re-initiation
|
NTCT Phase
n=26 participants at risk
nilotinib treatment continuation
|
TFR-2 Phase
n=2 participants at risk
treatment-free remission 2
|
NTRI-2 Phase
n=1 participants at risk
nilotinib treatment re-initiation 2
|
NTCT-P Phase
n=6 participants at risk
nilotinib treatment prolonged continuation
|
All Patients
n=163 participants at risk
All patients enrolled in the study
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
6/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.7%
6/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.1%
10/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
3/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.5%
9/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
8/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
5/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.7%
11/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.5%
9/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
FATIGUE
|
3.7%
6/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
3/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.4%
12/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.1%
10/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
5/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.6%
14/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.3%
7/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.7%
11/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.7%
11/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.7%
11/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.9%
8/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
30/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.8%
6/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.4%
43/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
3/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.3%
7/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.9%
10/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.2%
15/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.5%
17/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
23/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
11/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
9/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.9%
2/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.9%
21/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
HEADACHE
|
4.9%
8/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
5/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
16/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
2/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
1/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
6/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.3%
7/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.79%
1/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.8%
4/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.4%
12/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
HYPERTENSION
|
8.6%
14/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
7/126 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.7%
7/51 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/1 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.5%
22/163 • Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 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