Trial Outcomes & Findings for Shortening Treatment by Advancing Novel Drugs (NCT NCT02342886)
NCT ID: NCT02342886
Last Updated: 2019-03-26
Results Overview
Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy. A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following end of treatment (EOT), had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or were dying from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required an extension, restart or change of treatment except for reinfection/pregnancy, or failed to complete adequate treatment who were unassessable at 12 months or lost to follow-up/withdrawn before EOT.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
284 participants
Primary outcome timeframe
From Day 1 to Month 12.
Results posted on
2019-03-26
Participant Flow
Adult male and female patients with drug-sensitive (DS) and multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multicenter study.
Patients were confirmed sputum positive for tubercule bacilli on smear microscopy. DS-TB patients were required to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB patients were required to be resistant to rifampicin. Both DS and MDR-TB patients could be sensitive/resistant to isoniazid.
Participant milestones
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 milligrams (mg) moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE / 4 Months HR
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
71
|
67
|
68
|
13
|
|
Overall Study
Completed Month 12 Follow-Up
|
43
|
52
|
49
|
57
|
10
|
|
Overall Study
Completed Month 24 Follow-Up
|
40
|
47
|
46
|
53
|
10
|
|
Overall Study
COMPLETED
|
57
|
63
|
52
|
59
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
15
|
9
|
3
|
Reasons for withdrawal
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 milligrams (mg) moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE / 4 Months HR
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
|---|---|---|---|---|---|
|
Overall Study
Treatment non-compliance
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Late exclusion: rifampicin resistance
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse event/specific toxicity
|
4
|
3
|
11
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
2
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Investigator/sponsor decision
|
0
|
2
|
0
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Late exclusion: pyrazinamide resistance
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Shortening Treatment by Advancing Novel Drugs
Baseline characteristics by cohort
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
n=65 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=71 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=67 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE / 4 Months HR
n=68 Participants
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=13 Participants
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
275 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
87 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
197 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
65 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
284 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
191 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
44 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Month 12.Population: The MITT population included all randomized patients excluding late screening failures, lost to follow-up/withdrawn patients who were culture negative, pregnancy, accidental death during treatment, death during follow-up without TB relapse evidence, re-infection with new TB strain + missing/contaminated Month 12 sputum sample.
Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy. A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following end of treatment (EOT), had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or were dying from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required an extension, restart or change of treatment except for reinfection/pregnancy, or failed to complete adequate treatment who were unassessable at 12 months or lost to follow-up/withdrawn before EOT.
Outcome measures
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
n=57 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=61 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=56 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE / 4 Months HR
n=60 Participants
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=11 Participants
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
Note: The MDR-TB group was not randomized and not included in the analysis population.
|
|---|---|---|---|---|---|
|
Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population)
Favorable
|
38 Participants
|
46 Participants
|
43 Participants
|
52 Participants
|
10 Participants
|
|
Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population)
Unfavorable
|
19 Participants
|
15 Participants
|
13 Participants
|
8 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Month 12.Population: The PP population consisted of the MITT population, excluding patients who were lost to follow-up/withdrawn, had modified/extended treatment for reasons other than unfavourable therapeutic response, did not receive adequate amount of allocated study regimen and patients with major protocol deviations, unless already classified as unfavourable.
Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy. A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following EOT, had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or died from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required a restart or change of treatment because of an unfavorable outcome with or without bacteriological confirmation, ie, on bacteriological, radiographic or clinical grounds.
Outcome measures
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
n=52 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=57 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=47 Participants
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE / 4 Months HR
n=53 Participants
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=10 Participants
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
Note: The MDR-TB group was not randomized and not included in the analysis population.
|
|---|---|---|---|---|---|
|
Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Per Protocol [PP] Population)
Favorable
|
38 Participants
|
46 Participants
|
43 Participants
|
52 Participants
|
10 Participants
|
|
Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Per Protocol [PP] Population)
Unfavorable
|
14 Participants
|
11 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
Serious events: 3 serious events
Other events: 61 other events
Deaths: 4 deaths
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Serious events: 8 serious events
Other events: 62 other events
Deaths: 3 deaths
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Serious events: 8 serious events
Other events: 63 other events
Deaths: 3 deaths
DS-TB: 2 Months HRZE/ 4 Months HR
Serious events: 3 serious events
Other events: 62 other events
Deaths: 2 deaths
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
n=65 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=71 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=67 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE/ 4 Months HR
n=68 participants at risk
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=13 participants at risk
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.5%
3/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Lymph node Tuberculosis
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Nasal candidiasis
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
General disorders
Death
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
Other adverse events
| Measure |
DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide
n=65 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=71 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=67 participants at risk
Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
DS-TB: 2 Months HRZE/ 4 Months HR
n=68 participants at risk
Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24.
|
MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide
n=13 participants at risk
Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24.
|
|---|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
11.8%
8/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Eye disorders
Eye pain
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Eye disorders
Eyelid haematoma
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
15/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
14.1%
10/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
22.4%
15/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
25.0%
17/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
13/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
14.1%
10/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
20.9%
14/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
16.2%
11/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Blood uric acid increased
|
23.1%
15/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.5%
11/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
17.9%
12/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
11.8%
8/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.3%
8/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.5%
11/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
16.4%
11/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
17.6%
12/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Blood glucose increased
|
7.7%
5/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.9%
4/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
4/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.5%
3/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Protein urine present
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Investigations
Blood urine present
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
13/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.5%
11/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
16.4%
11/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
13/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
11.3%
8/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
9.0%
6/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.9%
4/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.5%
14/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
9.9%
7/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.5%
5/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
3/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.5%
5/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
15/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
33.8%
24/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
28.4%
19/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
22.1%
15/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
30.8%
4/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
3/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
9.9%
7/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
30.8%
20/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
29.6%
21/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
20.9%
14/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
32.4%
22/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
4/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.5%
5/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.5%
5/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Rhinitis
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Infections and infestations
Furuncle
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.1%
2/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
11.9%
8/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
16.2%
11/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
3/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.5%
3/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
8.8%
6/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.8%
2/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.2%
6/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
11.3%
8/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.5%
5/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.4%
3/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
7.7%
5/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.6%
4/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
30.8%
4/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
8.5%
6/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
10.4%
7/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Dizziness
|
4.6%
3/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.6%
4/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
10.4%
7/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.9%
4/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
15.4%
2/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
3.0%
2/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.9%
4/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
23.1%
3/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Somnolence
|
6.2%
4/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
2.9%
2/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Renal and urinary disorders
Haematuria
|
9.2%
6/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.2%
3/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.5%
3/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
9.2%
6/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
4.5%
3/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
5.9%
4/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
6.0%
4/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.4%
5/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.4%
1/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/65 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/71 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
1.5%
1/67 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
0.00%
0/68 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
7.7%
1/13 • Treatment emergent adverse events were collected from Day 1 up to and including 14 days after the last administration of trial medication (up to a maximum of 28 weeks).
The Safety analysis population included all patients in the randomized/assigned to trial medication population set who received at least 1 dose of trial medication. Patients were classified according to treatment received.
|
Additional Information
Leandra Lombard, Director, Clinical Operations
TB Alliance
Phone: +27 87 700 3900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator or any Sub-Investigator shall submit any oral or written publication or abstract concerning this study to the Sponsor not less than thirty (30) days prior to submission to any journal, other publication or meeting for review and removal of confidential information.
- Publication restrictions are in place
Restriction type: OTHER