Trial Outcomes & Findings for Treatment Shortening of MDR-TB Using Existing and New Drugs (NCT NCT02619994)
NCT ID: NCT02619994
Last Updated: 2025-01-03
Results Overview
To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
214 participants
Primary outcome timeframe
24 months after treatment start
Results posted on
2025-01-03
Participant Flow
Of the 443 eligible patients, 229 were excluded for the following reasons: * By the investigators' decision (n=102) * Declined to participate (n=65) * Met one of the exclusion criteria (n=58) * Laboratory abnormalities (n=42) * Ongoing use of prohibited drugs (n=10) * Unwilling to use proper contraceptives (n=3) * History of optic or peripheral neuropathy (n=3) * Other unspecified reason (n=4)
Participant milestones
| Measure |
Control Arm
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
108
|
|
Overall Study
COMPLETED
|
89
|
79
|
|
Overall Study
NOT COMPLETED
|
17
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Shortening of MDR-TB Using Existing and New Drugs
Baseline characteristics by cohort
| Measure |
Control Arm
n=89 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=79 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
49 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
89 participants
n=5 Participants
|
79 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Baseline Characteristics of Participants
|
89 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months after treatment startPopulation: mITT population Participant with \[not assessable\] was not included in the analysis
To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results)
Outcome measures
| Measure |
Control Arm
n=85 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=72 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Treatment Success Rate
|
60 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: through study completion (24 months after treatment start)Population: Participants with a positive baseline M.tuberculosis culture (liquid media) in the mITT population
To determine whether time to sputum culture conversion after treatment start is statistically different between the control and investigational arms, the median time will be estimated in each group using the Kaplan-Meier method, and the difference in the distribution of time to culture conversion of the two arms will be compared using the log-rank test.
Outcome measures
| Measure |
Control Arm
n=52 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=49 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Time to Sputum Culture Conversion After Treatment Start
|
24 day
Interval 7.0 to 56.0
|
27 day
Interval 7.0 to 55.0
|
SECONDARY outcome
Timeframe: At 2 months of treatmentPopulation: mITT population Participants with positive baseline sputum culture
Culture conversion rate at month 2 of treatment in participants with positive baseline sputum culture (liquid media).
Outcome measures
| Measure |
Control Arm
n=52 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=49 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Sputum Culture Conversion Proportion
|
42 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: At the end of treatmentPopulation: mITT populration One participant of experimental arm who became pregnant during the treatment was excluded
Treatment success rate at the end of treatment. * control arm (20-24 months) * experimental arm (40 or 52 weeks)
Outcome measures
| Measure |
Control Arm
n=89 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=78 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Treatment Success at the End of Treatment
|
64 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: At 24months after treatment startPopulation: mITT population Participant with \[not assessable\] was not included in the analysis
The proportion of patients who experienced a reversion between the end of treatment and up to 24 months after treatment start
Outcome measures
| Measure |
Control Arm
n=85 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=72 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Proportion of Reverting to Positive Sputum Culture After the End of Treatment
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 24months after treatment startPopulation: mITT population Participant with \[not assessable\] was not included in the analysis
Treatment success rate of participants with pyrazinamide resistance in the mITT analysis
Outcome measures
| Measure |
Control Arm
n=21 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=25 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Treatment Success According to Pyrazinamide Resistance (1)
|
13 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At 24months after treatment startPopulation: mITT population
The proportion of participants who died in the control and experimental arm mITT population
Outcome measures
| Measure |
Control Arm
n=89 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=79 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Proportion of Death Between the Control and Investigational Arms
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At 6 months of treatment startPopulation: mITT population participants with positive baseline sputum culture (liquid media)
Culture conversion rate at month 6 of treatment in participants with positive baseline sputum culture (liquid media).
Outcome measures
| Measure |
Control Arm
n=52 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=49 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Sputum Culture Conversion Proportion
|
45 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: At 24 months after treatment startPopulation: mITT population Participant with \[not assessable\] was not included in the analysis
Treatment success rate of participants without pyrazinamide resistance in the mITT analysis
Outcome measures
| Measure |
Control Arm
n=52 Participants
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=42 Participants
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Treatment Success According to Pyrazinamide Resistance (2)
|
41 Participants
|
32 Participants
|
Adverse Events
Control Arm
Serious events: 19 serious events
Other events: 87 other events
Deaths: 2 deaths
Experimental Arm
Serious events: 20 serious events
Other events: 78 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Control Arm
n=89 participants at risk
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=79 participants at risk
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Asthenia
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Pneumonia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Sepsis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Hepatitis B DNA increased
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Liver function test abnormal
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Completed suicide
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Surgical and medical procedures
Ligament operation
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Hypotension
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
Other adverse events
| Measure |
Control Arm
n=89 participants at risk
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.
* Treatment duration: for at least 20 months
Locally-used WHO-approved MDR-TB regimen in Korea
|
Experimental Arm
n=79 participants at risk
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
* Delamanid (100 mg bid for the entire treatment period)
* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)
* Levofloxacin (750 \~1000 mg/day)
* Pyrazinamide (1000\~ 2000 mg/day)
Linezolid
Delamanid
Levofloxacin
Pyrazinamide
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
6/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
36.7%
29/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Ear and labyrinth disorders
Tinnitus
|
7.9%
7/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Diabetic retinopathy
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Diplopia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Dry eye
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Eye pain
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Glare
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Ocular discomfort
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Vision blurred
|
9.0%
8/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
6.3%
5/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Visual acuity reduced
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Eye disorders
Visual impairment
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
6/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.0%
8/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
6.3%
5/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
16.9%
15/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
24.1%
19/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Dyspepsia
|
28.1%
25/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
20.3%
16/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Epigastric discomfort
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Glossodynia
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Lip ulceration
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
75.3%
67/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
72.2%
57/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Stomatitis
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
20/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
39.2%
31/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Asthenia
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
8.9%
7/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Chest discomfort
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Chest pain
|
5.6%
5/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Condition aggravated
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Fatigue
|
5.6%
5/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Feeling hot
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Generalised oedema
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Granuloma
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Localised oedema
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Malaise
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Oedema
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Oedema peripheral
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Pain
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Peripheral swelling
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Pyrexia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Hepatotoxicity
|
10.1%
9/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Bronchiolitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Dermatophytosis of nail
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Folliculitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Influenza
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
12/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Otitis media
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Pneumonia
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Rash pustular
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Rhinitis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Skin infection
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Tinea pedis
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
6/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Patella fracture
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
9.0%
8/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
11.2%
10/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Blood bilirubin increased
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Blood creatinine increased
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
8.9%
7/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Blood uric acid increased
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Colour vision tests abnormal
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
12.7%
10/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Intraocular pressure increased
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Liver function test abnormal
|
13.5%
12/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
11.4%
9/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Neutrophil count decreased
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Platelet count decreased
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
Weight decreased
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Investigations
White blood cell count decreased
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.5%
12/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
19.0%
15/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Gout
|
5.6%
5/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
23.6%
21/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
25.3%
20/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
5.1%
4/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
46.1%
41/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
32.9%
26/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
6.3%
5/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
6/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.6%
13/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
13.9%
11/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
5/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Amnesia
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Cranial nerve disorder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Dementia
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Disturbance in attention
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Dizziness
|
20.2%
18/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
10.1%
8/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Dysaesthesia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Dysarthria
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Dysgeusia
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Headache
|
10.1%
9/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
26.6%
21/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Hypoaesthesia
|
7.9%
7/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
6.3%
5/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Lethargy
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
19.0%
15/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Paraesthesia
|
6.7%
6/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
35.4%
28/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Polyneuropathy
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Somnolence
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Nervous system disorders
Tremor
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Anxiety
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Delirium
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Delusion
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Depression
|
5.6%
5/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
6.3%
5/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Hallucination, visual
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Insomnia
|
11.2%
10/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
13.9%
11/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Major depression
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Obsessive thoughts
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Psychotic disorder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Schizophrenia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Bladder disorder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Calculus bladder
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Calculus ureteric
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Micturition urgency
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
10/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
12.7%
10/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
3/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
4/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.3%
19/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
24.1%
19/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
7/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
10.1%
8/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
3.8%
3/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Flushing
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Hot flush
|
1.1%
1/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
0.00%
0/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Hypertension
|
2.2%
2/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
2.5%
2/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Hypotension
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/89 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
1.3%
1/79 • All adverse events and serious adverse events were collected during the entire 24-month study period.
Adverse Events were summarised according to the Common Terminology Criteria for Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place