Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis (NCT NCT02563327)
NCT ID: NCT02563327
Last Updated: 2026-08-27
Results Overview
To characterize rifapentine exposure (AUC0-24) using population pharmacokinetics.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2516 participants
Primary outcome timeframe
Plasma concentrations measured at approximately 0.5, 3, 5, 9, 12, and 24 hours after the pharmacokinetic reference dose during Weeks 2-8 after treatment initiation.
Results posted on
2026-08-27
Participant Flow
Participants were enrolled at 34 clinical research sites in 13 countries between January 2016 and October 2018. First participant was enrolled on 25 January 2016. Last participant was enrolled on 30 October 2018
Of 5124 patients screened, 2516 underwent randomization.
Participant milestones
| Measure |
Regimen 1 (2HRZE/4HR)
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
|
Regimen 2 (2HPZ/2HP)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
|
Regimen 3 (2HPZM/2HPM)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
|
|---|---|---|---|
|
Overall Study
STARTED
|
829
|
838
|
849
|
|
Overall Study
Microbiologically Eligible Analysis Population
|
768
|
784
|
791
|
|
Overall Study
Assessable Analysis Population
|
726
|
752
|
756
|
|
Overall Study
COMPLETED
|
661
|
702
|
689
|
|
Overall Study
NOT COMPLETED
|
168
|
136
|
160
|
Reasons for withdrawal
| Measure |
Regimen 1 (2HRZE/4HR)
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
|
Regimen 2 (2HPZ/2HP)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
|
Regimen 3 (2HPZM/2HPM)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
|
|---|---|---|---|
|
Overall Study
Death
|
7
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
2
|
|
Overall Study
Pregnancy
|
8
|
4
|
5
|
|
Overall Study
Baseline drug resistance
|
49
|
40
|
51
|
|
Overall Study
No baseline positive M. tuberculosis culture
|
4
|
6
|
3
|
|
Overall Study
Adverse Event
|
8
|
9
|
16
|
|
Overall Study
Consent withdrawn no AE reported
|
14
|
11
|
15
|
|
Overall Study
Consent withdrawn after occurrence of AE
|
2
|
3
|
3
|
|
Overall Study
Treatment changed for other reasons
|
7
|
4
|
4
|
|
Overall Study
Baseline Drug Resistance
|
49
|
40
|
51
|
|
Overall Study
No baseline positive culture
|
4
|
6
|
3
|
|
Overall Study
Protocol Violation
|
8
|
8
|
4
|
Baseline Characteristics
Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis
Baseline characteristics by cohort
| Measure |
Regimen 1 (2HRZE/4HR)
n=768 Participants
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
|
Regimen 2 (2HPZ/2HP)
n=784 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
|
Regimen 3 (2HPZM/2HPM)
n=791 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
|
Total
n=2343 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=31 Participants
|
19 Participants
n=49 Participants
|
25 Participants
n=80 Participants
|
63 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
743 Participants
n=31 Participants
|
755 Participants
n=49 Participants
|
755 Participants
n=80 Participants
|
2253 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=31 Participants
|
10 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
27 Participants
n=29 Participants
|
|
Age, Continuous
|
30.9 years
n=31 Participants
|
31 years
n=49 Participants
|
31 years
n=80 Participants
|
31 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=31 Participants
|
221 Participants
n=49 Participants
|
228 Participants
n=80 Participants
|
673 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
544 Participants
n=31 Participants
|
563 Participants
n=49 Participants
|
563 Participants
n=80 Participants
|
1670 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=31 Participants
|
20 Participants
n=49 Participants
|
27 Participants
n=80 Participants
|
74 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
287 Participants
n=31 Participants
|
283 Participants
n=49 Participants
|
297 Participants
n=80 Participants
|
867 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
454 Participants
n=31 Participants
|
481 Participants
n=49 Participants
|
467 Participants
n=80 Participants
|
1402 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
86 Participants
n=31 Participants
|
93 Participants
n=49 Participants
|
89 Participants
n=80 Participants
|
268 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
553 Participants
n=31 Participants
|
571 Participants
n=49 Participants
|
552 Participants
n=80 Participants
|
1676 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=31 Participants
|
8 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
36 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
111 Participants
n=31 Participants
|
111 Participants
n=49 Participants
|
135 Participants
n=80 Participants
|
357 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
|
Region of Enrollment
Africa
|
565 participants
n=31 Participants
|
573 participants
n=49 Participants
|
578 participants
n=80 Participants
|
1716 participants
n=29 Participants
|
|
Region of Enrollment
East Asia
|
86 participants
n=31 Participants
|
89 participants
n=49 Participants
|
88 participants
n=80 Participants
|
263 participants
n=29 Participants
|
|
Region of Enrollment
South America
|
109 participants
n=31 Participants
|
115 participants
n=49 Participants
|
115 participants
n=80 Participants
|
339 participants
n=29 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=31 Participants
|
7 participants
n=49 Participants
|
10 participants
n=80 Participants
|
25 participants
n=29 Participants
|
|
HIV status at baseline
HIV Negative
|
704 Participants
n=31 Participants
|
716 Participants
n=49 Participants
|
729 Participants
n=80 Participants
|
2149 Participants
n=29 Participants
|
|
HIV status at baseline
HIV Positive
|
64 Participants
n=31 Participants
|
68 Participants
n=49 Participants
|
62 Participants
n=80 Participants
|
194 Participants
n=29 Participants
|
|
Cavitation status at baseline
Cavitation on chest radiograph
|
558 Participants
n=31 Participants
|
573 Participants
n=49 Participants
|
572 Participants
n=80 Participants
|
1703 Participants
n=29 Participants
|
|
Cavitation status at baseline
No cavitation on chest radiograph
|
204 Participants
n=31 Participants
|
205 Participants
n=49 Participants
|
210 Participants
n=80 Participants
|
619 Participants
n=29 Participants
|
|
Cavitation status at baseline
Unknown
|
6 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
9 Participants
n=80 Participants
|
21 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Plasma concentrations measured at approximately 0.5, 3, 5, 9, 12, and 24 hours after the pharmacokinetic reference dose during Weeks 2-8 after treatment initiation.Population: Participants in the rifapentine-containing treatment arms with available rifapentine pharmacokinetic data. The rifampin control arm was not included because rifapentine pharmacokinetics were assessed only in participants receiving rifapentine-containing regimens.
To characterize rifapentine exposure (AUC0-24) using population pharmacokinetics.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=786 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
n=794 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Rifapentine Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24)
|
562.4 µg*h/mL
Interval 302.0 to 1037.0
|
557.1 µg*h/mL
Interval 276.0 to 983.0
|
PRIMARY outcome
Timeframe: Plasma concentrations measured during 0-24 hours following the pharmacokinetic reference dose; PK sampling performed during Weeks 2-8 after treatment initiation.Population: Participants in the rifapentine-containing treatment arms with available rifapentine pharmacokinetic data.
To characterize rifapentine peak concentration using population pharmacokinetic modeling.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=786 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
n=794 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Rifapentine Maximum Plasma Concentration (Cmax)
|
32.4 µg/mL
Interval 19.5 to 53.4
|
32.8 µg/mL
Interval 19.2 to 51.9
|
SECONDARY outcome
Timeframe: Efficacy assessed through 12 months after treatment initiation; pharmacokinetics assessed during Weeks 2-8.Population: Microbiologically eligible participants assigned to Regimen 3 (2HPZM/2HPM). The descriptive outcome includes 791 participants. Separate complete-case exposure-response models evaluated rifapentine and moxifloxacin pharmacokinetics.
Number of microbiologically eligible participants with TB-related unfavorable outcomes in the rifapentine-moxifloxacin regimen through 12 months after treatment initiation. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=791 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Number of Participants With TB-Related Unfavorable Outcomes in the Rifapentine-Moxifloxacin Regimen
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.Population: Safety population participants in the two rifapentine-containing treatment arms who received at least one dose of study treatment. Exposure-response analyses used the subsets with available pharmacokinetic data, as described in the Statistical Analysis sections.
Number of participants with grade 3 or higher adverse events during the treatment period in each rifapentine-containing treatment arm. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=835 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
n=846 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
119 participants
|
159 participants
|
SECONDARY outcome
Timeframe: Weeks 2 through 8 after treatment initiation.Population: Participants in 2HPZM/2HPM regimen with available moxifloxacin pharmacokinetic data.
To characterize moxifloxacin pharmacokinetics when moxifloxacin was administered 400 mg daily with rifapentine 1200 mg daily.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=774 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Moxifloxacin Area Under the Concentration-Time Curve at Steady State
|
24.3 µg*h/mL
Interval 15.2 to 45.4
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.Population: Participants receiving the rifapentine-moxifloxacin regimen with available moxifloxacin pharmacokinetic and safety outcome data included in the safety analysis.
Number of participants with grade 3 or higher adverse events in the rifapentine-moxifloxacin regimen during the treatment period. The association between moxifloxacin exposure and safety outcomes was evaluated using multivariable logistic regression and is reported in the Statistical Analysis section.
Outcome measures
| Measure |
Regimen 2 (2HPZ/2HP)
n=774 Participants
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by nine weeks of daily treatment with rifapentine and isoniazid.
|
Regimen 3 (2HPZM/2HPM)
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events in the Rifapentine-Moxifloxacin Regimen
|
159 participants
|
—
|
Adverse Events
Regimen 1 (2HRZE/4HR)
Serious events: 56 serious events
Other events: 74 other events
Deaths: 7 deaths
Regimen 2 (2HPZ/2HP)
Serious events: 39 serious events
Other events: 61 other events
Deaths: 4 deaths
Regimen 3 (2HPZM/2HPM)
Serious events: 37 serious events
Other events: 94 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Regimen 1 (2HRZE/4HR)
n=825 participants at risk
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
|
Regimen 2 (2HPZ/2HP)
n=835 participants at risk
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
|
Regimen 3 (2HPZM/2HPM)
n=846 participants at risk
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.36%
3/825 • Number of events 3 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.24%
2/846 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Eye disorders
DIABETIC RETINOPATHY
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
General disorders
DEATH
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
General disorders
DRUG INTOLERANCE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
General disorders
PYREXIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Hepatobiliary disorders
HEPATITIS
|
1.2%
10/825 • Number of events 10 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.60%
5/835 • Number of events 5 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.83%
7/846 • Number of events 7 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
BONE TUBERCULOSIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
EXTRAPULMONARY TUBERCULOSIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
HEPATITIS C
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
PARACOCCIDIOIDES INFECTION
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
PNEUMONIA
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.35%
3/846 • Number of events 3 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
SEPSIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Infections and infestations
TUBERCULOSIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
CHEST INJURY
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
DOCUMENTED HYPERSENSITIVITY TO ADMINISTERED PRODUCT
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
STAB WOUND
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.24%
2/835 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMOTHORAX
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Metabolism and nutrition disorders
GOUT
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Musculoskeletal and connective tissue disorders
SACROILIITIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE TONGUE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
SEIZURE
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Nervous system disorders
TEMPORAL LOBE EPILEPSY
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Pregnancy, puerperium and perinatal conditions
COMPLICATION OF PREGNANCY
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.24%
2/825 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.36%
3/835 • Number of events 3 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.24%
2/846 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Psychiatric disorders
DISORIENTATIO
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.61%
5/825 • Number of events 5 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.48%
4/835 • Number of events 4 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.24%
2/825 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Skin and subcutaneous tissue disorders
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/825 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/835 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.35%
3/846 • Number of events 3 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.12%
1/825 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/835 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.00%
0/846 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.36%
3/825 • Number of events 3 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.24%
2/835 • Number of events 2 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
0.12%
1/846 • Number of events 1 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
Other adverse events
| Measure |
Regimen 1 (2HRZE/4HR)
n=825 participants at risk
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
|
Regimen 2 (2HPZ/2HP)
n=835 participants at risk
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
|
Regimen 3 (2HPZM/2HPM)
n=846 participants at risk
Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
|
|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.8%
48/825 • Number of events 187 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
4.1%
34/835 • Number of events 130 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
6.6%
56/846 • Number of events 184 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
|
Hepatobiliary disorders
Hepatitis
|
3.2%
26/825 • Number of events 187 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
3.2%
27/835 • Number of events 130 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
4.5%
38/846 • Number of events 184 • From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days)
The Safety analysis population included all the randomized patients and received at least 1 dose of trial medication. Patients were classified according to Regimen received. Grade 3 or higher Adverse Events per CTCAE V4.01 are collected in systematic way through the laboratory tests and physical exam at regular study visits and also non-systematic way when it was self-reported by participants during the visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place