Trial Outcomes & Findings for Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design (NCT NCT01785186)
NCT ID: NCT01785186
Last Updated: 2017-09-20
Results Overview
From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
365 participants
Primary outcome timeframe
0 - 12 weeks
Results posted on
2017-09-20
Participant Flow
Participant milestones
| Measure |
HRZQ
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
Arm 1 (R35)
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
63
|
57
|
63
|
123
|
|
Overall Study
COMPLETED
|
53
|
57
|
52
|
58
|
117
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
5
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
Baseline characteristics by cohort
| Measure |
HRZQ
n=59 Participants
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
Arm 1 (R35)
n=63 Participants
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=57 Participants
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=63 Participants
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=123 Participants
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
32 years
n=5 Participants
|
33 years
n=7 Participants
|
34 years
n=5 Participants
|
31 years
n=4 Participants
|
34 years
n=21 Participants
|
32.9 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
107 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
258 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
300 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
HIV Positive Participants
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
24 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 0 - 12 weeksPopulation: Modified intention to treat analysis
From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.
Outcome measures
| Measure |
Arm 1 (R35)
n=63 Participants
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HRZQ
n=58 Participants
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=56 Participants
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=63 Participants
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=123 Participants
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media
|
48 days
Interval 34.0 to 69.0
|
63 days
Interval 48.0 to 83.0
|
66 days
Interval 41.0 to 83.0
|
55 days
Interval 41.0 to 69.0
|
62 days
Interval 41.0 to 83.0
|
SECONDARY outcome
Timeframe: 0 - 12 weeksAll Adverse Events (AE), and AEs considered to be drug-related will coded using standard AE dictionaries.
Outcome measures
| Measure |
Arm 1 (R35)
n=63 Participants
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HRZQ
n=58 Participants
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=56 Participants
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=63 Participants
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=123 Participants
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Frequency of Adverse Events
Number of Patients with at least 1 AE
|
53 participants
|
49 participants
|
42 participants
|
49 participants
|
92 participants
|
|
Frequency of Adverse Events
Number of patients with at least 1 SAE
|
4 participants
|
4 participants
|
5 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 0 - 12 weeksCultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed as follows: * Identification of M. tuberculosis complex and RIF resistance by PCR (GeneXpert MTB/RIF®), * First-line drug susceptibility testing of the M. tuberculosis isolates using the MGIT system for sensitivity to rifampicin; isoniazid, pyrazinamide, moxifloxacin or ethambutol. * Minimum inhibitory concentrations (MIC) of SQ109, rifampicin and moxifloxacin. * Typing of the infecting strain(s) by molecular methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksPopulation: Pharmacokinetic population
Pharmacokinetic parameters will be assessed for rifampicin, moxifloxacin and SQ109: * area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0-24) (in h\*ng/mL) * the observed maximum concentration (Cmax( (in ng/mL) * time to reach Cmax (Tmax)(in hours) * the minimum observed plasma concentration 24 hours following the last dose (Cmin) (in hours), * clearance (Cl) (in mL/minute), * volume of distribution (Vd) (in L), * elimination half-life (T1/2,) (in hours) * free (protein-unbound) fraction (for rifampicin only) (in percent).
Outcome measures
| Measure |
Arm 1 (R35)
n=19 Participants
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HRZQ
n=20 Participants
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=19 Participants
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=19 Participants
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=19 Participants
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding
|
17.4 Rifampicin AUC(mg*h/l)
Interval 4.3 to 45.3
|
170 Rifampicin AUC(mg*h/l)
Interval 103.0 to 266.0
|
68.3 Rifampicin AUC(mg*h/l)
Interval 38.5 to 149.0
|
57.8 Rifampicin AUC(mg*h/l)
Interval 15.0 to 121.0
|
24.2 Rifampicin AUC(mg*h/l)
Interval 11.9 to 52.5
|
SECONDARY outcome
Timeframe: 0 - 12 weeksBy combining pharmacokinetic parameters and MIC values (see below), the pharmacodynamic indices AUC0-24/MIC (h\*ng/mL) and Cmax/MIC (ng/mL) will be calculated for individual patients for experimental drugs administered. Pharmacokinetic parameters and pharmacodynamic indices will be related to efficacy and safety/tolerability endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksTime to a convert to a single negative culture on liquid and solid media
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksProportion of patients converting to negative sputum culture (2 consecutive weekly cultures) in liquid and solid media
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksRate of change in time to positivity in BD MGIT 960® liquid culture
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksGeneXpert MTB/RIF (Xpert) quantitative PCR results (counts per week
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksFrequency of treatment failures (number of patients with relapse and/or development of drug resistance) will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 - 12 weeksFrequency tables will be generated for visual acuity tests, 12 lead ECGs, clinical chemistry metrics, haematology, and urinalysis
Outcome measures
Outcome data not reported
Adverse Events
HRZQ
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Arm 1 (R35)
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
HR20ZQ
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
HR20ZM
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
HRZE
Serious events: 6 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HRZQ
n=59 participants at risk
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
Arm 1 (R35)
n=63 participants at risk
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=57 participants at risk
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=63 participants at risk
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=123 participants at risk
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Arthritis of ankles
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Acute Dyspnoea
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Nervous system disorders
Seizure
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
5.3%
3/57 • Number of events 3
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
left pneumothorax
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Hepatobiliary disorders
Intrahepatic cholestasis
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Psychiatric disorders
Parasuicide
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Resiratory insufficiency secondary to psnumonia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Blood and lymphatic system disorders
haemoptysis
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cerebral fractures due to post motor vehicle accident
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Community accuired pneumonia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Multi drug resistant TB
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Death
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Immune system disorders
Fever - hospitalization
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Endocrine disorders
hyper osmolar hyperglycaemia state (diabetic melitus) grade 4
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
Other adverse events
| Measure |
HRZQ
n=59 participants at risk
Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
Arm 1 (R35)
n=63 participants at risk
Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZQ
n=57 participants at risk
Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
SQ109: SQ109 300 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HR20ZM
n=63 participants at risk
Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
Rifampicin: Rifampicin 10 to 35 mg/kg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
pyridoxine: pyridoxine 25 mg
|
HRZE
n=123 participants at risk
HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol
Rifampicin: Rifampicin 10 to 35 mg/kg
Moxifloxacin: Moxifloxacin 400mg
isoniazid: isoniazid 75 mg
pyrazinamide: pyrazinamide 400 mg
ethambutol: ethambutol 275 mg
pyridoxine: pyridoxine 25 mg
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • Number of events 3
|
1.6%
1/63 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
3.2%
2/63 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Abcess of eyelid
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.7%
1/59 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
0.00%
0/57
|
4.8%
3/63 • Number of events 3
|
4.9%
6/123 • Number of events 6
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Ageusia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
2/59 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 2
|
3.2%
2/63 • Number of events 2
|
1.6%
2/123 • Number of events 2
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
2/59 • Number of events 2
|
3.2%
2/63 • Number of events 2
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
4.9%
6/123 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
7/59 • Number of events 8
|
12.7%
8/63 • Number of events 8
|
10.5%
6/57 • Number of events 7
|
15.9%
10/63 • Number of events 10
|
14.6%
18/123 • Number of events 19
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
2/59 • Number of events 2
|
3.2%
2/63 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
6.3%
4/63 • Number of events 4
|
2.4%
3/123 • Number of events 3
|
|
General disorders
Asthenia
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
3/59 • Number of events 3
|
0.00%
0/63
|
3.5%
2/57 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
2.4%
3/123 • Number of events 3
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Investigations
Blood albumine decreased
|
1.7%
1/59 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/59
|
3.2%
2/63 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
4.8%
3/63 • Number of events 3
|
0.00%
0/123
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Investigations
Blood potassium increased
|
0.00%
0/59
|
0.00%
0/63
|
5.3%
3/57 • Number of events 3
|
0.00%
0/63
|
0.00%
0/123
|
|
Investigations
Blood pressure increased
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Infections and infestations
Body tinea
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
0.00%
0/123
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
10.2%
6/59 • Number of events 6
|
6.3%
4/63 • Number of events 5
|
7.0%
4/57 • Number of events 4
|
3.2%
2/63 • Number of events 2
|
4.9%
6/123 • Number of events 6
|
|
Eye disorders
Conjunctival discolouration
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Immune system disorders
Conjunctivitis allergic
|
1.7%
1/59 • Number of events 3
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • Number of events 2
|
3.2%
2/63 • Number of events 3
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/59 • Number of events 2
|
0.00%
0/63
|
0.00%
0/57
|
3.2%
2/63 • Number of events 3
|
1.6%
2/123 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
3/59 • Number of events 3
|
1.6%
1/63 • Number of events 1
|
5.3%
3/57 • Number of events 3
|
3.2%
2/63 • Number of events 2
|
4.9%
6/123 • Number of events 7
|
|
General disorders
Dental caries
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
4/59 • Number of events 5
|
3.2%
2/63 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
7.9%
5/63 • Number of events 5
|
3.3%
4/123 • Number of events 4
|
|
Immune system disorders
Drug eruption
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Hepatobiliary disorders
drug induced liver injury
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Eye disorders
Dry eye
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
duodenitis
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
3.5%
2/57 • Number of events 3
|
1.6%
1/63 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
Excema
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Cardiac disorders
Electrocardiogram QT prolonged
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
7.9%
5/63 • Number of events 6
|
0.00%
0/123
|
|
Eye disorders
Eye irrritation
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Fatigue
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
General disorders
feeling cold
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
fungal skin infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Blood and lymphatic system disorders
GGT increased
|
0.00%
0/59
|
3.2%
2/63 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
3.2%
2/63 • Number of events 2
|
1.6%
2/123 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
gastroentertitis bacterial
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Generalized oedema
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Immune system disorders
goitre
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Blood and lymphatic system disorders
Haematemesis
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Blood and lymphatic system disorders
haemoptysis
|
11.9%
7/59 • Number of events 10
|
4.8%
3/63 • Number of events 3
|
7.0%
4/57 • Number of events 4
|
7.9%
5/63 • Number of events 5
|
5.7%
7/123 • Number of events 10
|
|
General disorders
haemarrhoids
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
General disorders
headache
|
10.2%
6/59 • Number of events 8
|
7.9%
5/63 • Number of events 5
|
7.0%
4/57 • Number of events 4
|
6.3%
4/63 • Number of events 6
|
8.9%
11/123 • Number of events 11
|
|
Cardiac disorders
heart rate increased
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Hepatobiliary disorders
hepatic enzyme increased
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
1.6%
2/123 • Number of events 2
|
|
Hepatobiliary disorders
hepatotoxicity
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
herpes simplex
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
herplex zoster
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Hordeolum
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
hypercholsterolaemia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Endocrine disorders
hyperglycaemia
|
1.7%
1/59 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
0.00%
0/57
|
1.6%
1/63 • Number of events 2
|
0.81%
1/123 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/59
|
3.2%
2/63 • Number of events 2
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
2.4%
3/123 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
2/59 • Number of events 2
|
4.8%
3/63 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
3.3%
4/123 • Number of events 4
|
|
Infections and infestations
Influenza
|
8.5%
5/59 • Number of events 5
|
6.3%
4/63 • Number of events 4
|
1.8%
1/57 • Number of events 1
|
6.3%
4/63 • Number of events 4
|
5.7%
7/123 • Number of events 7
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Investigations
International normalised ratio increased
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
2.4%
3/123 • Number of events 3
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/59
|
1.6%
1/63 • Number of events 2
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Lipase
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Investigations
Lipase decreased
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Lipase increased
|
3.4%
2/59 • Number of events 2
|
6.3%
4/63 • Number of events 4
|
7.0%
4/57 • Number of events 5
|
3.2%
2/63 • Number of events 2
|
1.6%
2/123 • Number of events 2
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Infections and infestations
Malaria
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Mass
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
0.81%
1/123 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1
|
3.2%
2/63 • Number of events 3
|
7.0%
4/57 • Number of events 4
|
3.2%
2/63 • Number of events 2
|
1.6%
2/123 • Number of events 2
|
|
Eye disorders
Myopia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 3
|
3.3%
4/123 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
11.9%
7/59 • Number of events 7
|
14.3%
9/63 • Number of events 9
|
14.0%
8/57 • Number of events 8
|
11.1%
7/63 • Number of events 9
|
5.7%
7/123 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/59
|
7.9%
5/63 • Number of events 5
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
3.3%
4/123 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Night sweats
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Oedema peripheral
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
3.5%
2/57 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Optic neuritis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Otitis media
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
3/59 • Number of events 3
|
4.8%
3/63 • Number of events 3
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
1.6%
2/123 • Number of events 2
|
|
General disorders
Pain in face
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Pericarditis tuberculous
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.7%
1/59 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 3
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Pregnancy test false positive
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
Protein urine present
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
6/59 • Number of events 6
|
17.5%
11/63 • Number of events 14
|
8.8%
5/57 • Number of events 6
|
14.3%
9/63 • Number of events 9
|
13.8%
17/123 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Pyrexia
|
3.4%
2/59 • Number of events 3
|
4.8%
3/63 • Number of events 3
|
5.3%
3/57 • Number of events 3
|
3.2%
2/63 • Number of events 3
|
4.1%
5/123 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
5/59 • Number of events 5
|
7.9%
5/63 • Number of events 5
|
10.5%
6/57 • Number of events 6
|
7.9%
5/63 • Number of events 5
|
4.1%
5/123 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
2.4%
3/123 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.7%
1/59 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
1.6%
2/123 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.4%
2/59 • Number of events 3
|
3.2%
2/63 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
2.4%
3/123 • Number of events 3
|
|
Infections and infestations
Rash pustular
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Respiratory tract infection
|
3.4%
2/59 • Number of events 2
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Immune system disorders
Rhinitis seasonal
|
1.7%
1/59 • Number of events 2
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
1.6%
2/123 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Immune system disorders
Seasonal allergy
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Investigations
Serum ferritin increased
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Sinusitis
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
General disorders
Suprapubic pain
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
0.81%
1/123 • Number of events 1
|
|
General disorders
Tenderness
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 2
|
0.00%
0/63
|
0.00%
0/123
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Tinea infection
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Gastrointestinal disorders
Tongue ulceration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
2.4%
3/123 • Number of events 3
|
|
Investigations
Transaminases increased
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 2
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • Number of events 3
|
0.00%
0/63
|
0.00%
0/57
|
3.2%
2/63 • Number of events 2
|
3.3%
4/123 • Number of events 6
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Infections and infestations
Urogenital infection bacterial
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.4%
2/59 • Number of events 4
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Eye disorders
Vision blurred
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
0.00%
0/63
|
0.00%
0/123
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Eye disorders
Visual acuity reduced transiently
|
0.00%
0/59
|
0.00%
0/63
|
1.8%
1/57 • Number of events 1
|
0.00%
0/63
|
0.00%
0/123
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
5/59 • Number of events 6
|
17.5%
11/63 • Number of events 11
|
14.0%
8/57 • Number of events 8
|
12.7%
8/63 • Number of events 9
|
12.2%
15/123 • Number of events 16
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.4%
2/59 • Number of events 2
|
0.00%
0/63
|
0.00%
0/57
|
6.3%
4/63 • Number of events 4
|
1.6%
2/123 • Number of events 3
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/59
|
1.6%
1/63 • Number of events 1
|
0.00%
0/57
|
0.00%
0/63
|
0.81%
1/123 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/59
|
3.2%
2/63 • Number of events 2
|
0.00%
0/57
|
0.00%
0/63
|
1.6%
2/123 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/59
|
0.00%
0/63
|
0.00%
0/57
|
1.6%
1/63 • Number of events 1
|
0.00%
0/123
|
Additional Information
Dr. Norbert Heinrich
Tropical Institute of the Ludwig-Maximilians University in Munich, Germany
Phone: 0049 89 2180 17605
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER