Trial Outcomes & Findings for A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456) (NCT NCT01865487)
NCT ID: NCT01865487
Last Updated: 2019-12-19
Results Overview
Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Up to 10 months
Results posted on
2019-12-19
Participant Flow
Participant milestones
| Measure |
Group 1: 2-dose 5/500
5/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose 15/500
15/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose 50/500
50/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose Placebo
Placebo, QFT Negative, 2 doses, days 0 and 56
|
Group 2: 3-dose 5/500
5/500 H56ug/IC31nmol, QFT Negative, 3 doses, days 0, 56, 112
|
Group 2: 3-dose Placebo
Placebo, QFT Negative, 3 doses, days 0, 56, 112
|
Group 3: 2-dose 5/500
5/500 H56ug/IC31nmol, QFT Positive, 2 doses, Days 0 and 56
|
Group 3: 2-dose Placebo
Placebo, QFT Positive, 2 doses, Days 0 and 56
|
Group 4: 3-dose 5/500
5/500 H56ug/IC31nmol, QFT Positive, 3 doses, days 0, 56, 112
|
Group 4: 3-dose Placebo
Placebo, QFT positive, 3 doses, Days 0, 56, 112
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
5
|
12
|
4
|
12
|
4
|
12
|
4
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
4
|
11
|
4
|
11
|
4
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: 2-dose 5/500
5/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose 15/500
15/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose 50/500
50/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56
|
Group 1: 2-dose Placebo
Placebo, QFT Negative, 2 doses, days 0 and 56
|
Group 2: 3-dose 5/500
5/500 H56ug/IC31nmol, QFT Negative, 3 doses, days 0, 56, 112
|
Group 2: 3-dose Placebo
Placebo, QFT Negative, 3 doses, days 0, 56, 112
|
Group 3: 2-dose 5/500
5/500 H56ug/IC31nmol, QFT Positive, 2 doses, Days 0 and 56
|
Group 3: 2-dose Placebo
Placebo, QFT Positive, 2 doses, Days 0 and 56
|
Group 4: 3-dose 5/500
5/500 H56ug/IC31nmol, QFT Positive, 3 doses, days 0, 56, 112
|
Group 4: 3-dose Placebo
Placebo, QFT positive, 3 doses, Days 0, 56, 112
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
Baseline characteristics by cohort
| Measure |
2-Dose Placebo
n=9 Participants
Placebo, QFT Neg and Pos, 2 doses day 0 and 56
|
2-Dose 5/500 H56/IC31nmol
n=27 Participants
5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
|
2-Dose 15/500 H56/IC31nmol
n=15 Participants
15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
|
2-Dose 50/500 H56/IC31nmol
n=15 Participants
50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
|
3-Dose Placebo
n=8 Participants
Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
|
3-Dose 5/500 H56/IC31nmol
n=24 Participants
5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 9.51 • n=99 Participants
|
27.2 years
STANDARD_DEVIATION 8.71 • n=107 Participants
|
24.3 years
STANDARD_DEVIATION 4.08 • n=206 Participants
|
25.3 years
STANDARD_DEVIATION 8.76 • n=7 Participants
|
24.9 years
STANDARD_DEVIATION 8.25 • n=31 Participants
|
28.4 years
STANDARD_DEVIATION 8.34 • n=30 Participants
|
26.6 years
STANDARD_DEVIATION 8.06 • n=3 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
66 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
38 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
4 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
60 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Baseline BMI
|
26.83 kg/m^2
STANDARD_DEVIATION 8.385 • n=99 Participants
|
27.11 kg/m^2
STANDARD_DEVIATION 6.655 • n=107 Participants
|
25.74 kg/m^2
STANDARD_DEVIATION 8.122 • n=206 Participants
|
31.14 kg/m^2
STANDARD_DEVIATION 10.922 • n=7 Participants
|
27.75 kg/m^2
STANDARD_DEVIATION 12.612 • n=31 Participants
|
25.56 kg/m^2
STANDARD_DEVIATION 5.726 • n=30 Participants
|
27.17 kg/m^2
STANDARD_DEVIATION 8.191 • n=3 Participants
|
|
LTBI Status at Baseline
LTBI Negative
|
5 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
66 Participants
n=3 Participants
|
|
LTBI Status at Baseline
LTBI Positivie
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 10 monthsPopulation: Safety analysis set
Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.
Outcome measures
| Measure |
Placebo QFT Neg
n=9 Participants
2-doses and 3-doses (Groups 1 and 2)
|
Placebo QFT Pos
n=8 Participants
2-doses and 3-doses (Groups 3 and 4)
|
2-Doses 5/500 QFT Neg
n=15 Participants
QFT Negative (Group 1)
|
2-Doses 15/500
n=15 Participants
QFT Negative (Group 1)
|
2-Doses 50/500
n=15 Participants
QFT Negative (Group 1)
|
3-Doses 5/500 QFT Neg
n=12 Participants
QFT Negative (Group 2)
|
2-Doses 5/500 QFT Pos
n=12 Participants
QFT Positive (Group 3)
|
3-Doses 5/500 QFT Pos
n=12 Participants
QFT Positive (Group 4)
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Participants with AEs
|
7 Participants
|
8 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Participants with SAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Participants with related AEs
|
5 Participants
|
4 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 292Population: Immunogenicity analysis set: LTBI-negative at baseline
LTBI: Latent TB Infection QFT: QuantiFERON-TB Gold Plus (QFT-Plus) is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline 13-color ICS assay using PBMCs T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any
Outcome measures
| Measure |
Placebo QFT Neg
n=4 Participants
2-doses and 3-doses (Groups 1 and 2)
|
Placebo QFT Pos
n=13 Participants
2-doses and 3-doses (Groups 3 and 4)
|
2-Doses 5/500 QFT Neg
n=14 Participants
QFT Negative (Group 1)
|
2-Doses 15/500
n=14 Participants
QFT Negative (Group 1)
|
2-Doses 50/500
n=3 Participants
QFT Negative (Group 1)
|
3-Doses 5/500 QFT Neg
n=6 Participants
QFT Negative (Group 2)
|
2-Doses 5/500 QFT Pos
QFT Positive (Group 3)
|
3-Doses 5/500 QFT Pos
QFT Positive (Group 4)
|
|---|---|---|---|---|---|---|---|---|
|
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative)
|
0.002 Percentage of change from baseline
Standard Deviation 0.018
|
0.088 Percentage of change from baseline
Standard Deviation 0.104
|
0.027 Percentage of change from baseline
Standard Deviation 0.031
|
0.031 Percentage of change from baseline
Standard Deviation 0.047
|
0.012 Percentage of change from baseline
Standard Deviation 0.014
|
0.045 Percentage of change from baseline
Standard Deviation 0.056
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 292Population: Immunogenicity analysis set: LTBI-positive at baseline
Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline. 13-color ICS assay using PBMCs. T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any
Outcome measures
| Measure |
Placebo QFT Neg
n=4 Participants
2-doses and 3-doses (Groups 1 and 2)
|
Placebo QFT Pos
n=10 Participants
2-doses and 3-doses (Groups 3 and 4)
|
2-Doses 5/500 QFT Neg
n=4 Participants
QFT Negative (Group 1)
|
2-Doses 15/500
n=8 Participants
QFT Negative (Group 1)
|
2-Doses 50/500
QFT Negative (Group 1)
|
3-Doses 5/500 QFT Neg
QFT Negative (Group 2)
|
2-Doses 5/500 QFT Pos
QFT Positive (Group 3)
|
3-Doses 5/500 QFT Pos
QFT Positive (Group 4)
|
|---|---|---|---|---|---|---|---|---|
|
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive)
|
0.005 Percentage of change from baseline
Standard Deviation 0.020
|
0.068 Percentage of change from baseline
Standard Deviation 0.052
|
0.027 Percentage of change from baseline
Standard Deviation 0.022
|
0.097 Percentage of change from baseline
Standard Deviation 0.170
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 292Population: Immunogenicity analysis set
DMSO-subtracted Antigen-specific IFN-gamma ELISpot Response (SFU - Background/10\^6 PBMC) Change from Baseline LTBI Status at Baseline: Total Stimulation Antigen: Total
Outcome measures
| Measure |
Placebo QFT Neg
n=8 Participants
2-doses and 3-doses (Groups 1 and 2)
|
Placebo QFT Pos
n=21 Participants
2-doses and 3-doses (Groups 3 and 4)
|
2-Doses 5/500 QFT Neg
n=13 Participants
QFT Negative (Group 1)
|
2-Doses 15/500
n=12 Participants
QFT Negative (Group 1)
|
2-Doses 50/500
n=7 Participants
QFT Negative (Group 1)
|
3-Doses 5/500 QFT Neg
n=13 Participants
QFT Negative (Group 2)
|
2-Doses 5/500 QFT Pos
QFT Positive (Group 3)
|
3-Doses 5/500 QFT Pos
QFT Positive (Group 4)
|
|---|---|---|---|---|---|---|---|---|
|
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot
|
82.7 Number of spots per well
Standard Deviation 223.6
|
209.0 Number of spots per well
Standard Deviation 221.8
|
57.9 Number of spots per well
Standard Deviation 162.2
|
110.0 Number of spots per well
Standard Deviation 92.0
|
-53.1 Number of spots per well
Standard Deviation 79.8
|
167.4 Number of spots per well
Standard Deviation 364.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Study Day 292Population: Conversion of LTBI-negative at baseline to LTBI-positive due to H56:IC31 expression of ESAT-6 (antigen in QFT assay).
QFT results were summarized using subject count (percentage) for qualitative results. Number of participants QFT-positive at any time point.
Outcome measures
| Measure |
Placebo QFT Neg
n=9 Participants
2-doses and 3-doses (Groups 1 and 2)
|
Placebo QFT Pos
n=15 Participants
2-doses and 3-doses (Groups 3 and 4)
|
2-Doses 5/500 QFT Neg
n=15 Participants
QFT Negative (Group 1)
|
2-Doses 15/500
n=15 Participants
QFT Negative (Group 1)
|
2-Doses 50/500
n=12 Participants
QFT Negative (Group 1)
|
3-Doses 5/500 QFT Neg
QFT Negative (Group 2)
|
2-Doses 5/500 QFT Pos
QFT Positive (Group 3)
|
3-Doses 5/500 QFT Pos
QFT Positive (Group 4)
|
|---|---|---|---|---|---|---|---|---|
|
Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
Adverse Events
2-Dose Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
2-Dose 5/500 H56ug/IC31nmol
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
2-Dose 15/500 H56ug/IC31nmol
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
2-Dose 50/500 H56ug/IC31nmol
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
3-Dose Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3-Dose 5/500 H56ug/IC31nmol
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2-Dose Placebo
n=9 participants at risk
Placebo QFT neg and pos
|
2-Dose 5/500 H56ug/IC31nmol
n=27 participants at risk
2-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
|
2-Dose 15/500 H56ug/IC31nmol
n=15 participants at risk
2-Dose 15/500 H56ug/IC31nmol, QFT negative
|
2-Dose 50/500 H56ug/IC31nmol
n=15 participants at risk
2-Dose 50/500 H56ug/IC31nmol, QFT negative
|
3-Dose Placebo
n=8 participants at risk
3-Dose Placebo QFT neg and pos
|
3-Dose 5/500 H56ug/IC31nmol
n=24 participants at risk
3-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
Other adverse events
| Measure |
2-Dose Placebo
n=9 participants at risk
Placebo QFT neg and pos
|
2-Dose 5/500 H56ug/IC31nmol
n=27 participants at risk
2-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
|
2-Dose 15/500 H56ug/IC31nmol
n=15 participants at risk
2-Dose 15/500 H56ug/IC31nmol, QFT negative
|
2-Dose 50/500 H56ug/IC31nmol
n=15 participants at risk
2-Dose 50/500 H56ug/IC31nmol, QFT negative
|
3-Dose Placebo
n=8 participants at risk
3-Dose Placebo QFT neg and pos
|
3-Dose 5/500 H56ug/IC31nmol
n=24 participants at risk
3-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
20.0%
3/15 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Chills
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
26.7%
4/15 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
18.5%
5/27 • Number of events 5 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
20.0%
3/15 • Number of events 6 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
33.3%
5/15 • Number of events 7 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
25.0%
2/8 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
7.4%
2/27 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Injection site pain
|
22.2%
2/9 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
51.9%
14/27 • Number of events 19 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
33.3%
5/15 • Number of events 10 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
53.3%
8/15 • Number of events 11 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
29.2%
7/24 • Number of events 12 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Injection site swelling
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
7.4%
2/27 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Injection site warmth
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Malaise
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
General disorders
Pyrexia
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
7.4%
2/27 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
7.4%
2/27 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Infections and infestations
Wound infection
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
3/24 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
11.1%
3/27 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
25.0%
2/8 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
3/24 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Blood urine present
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
11.1%
3/27 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Heart rate decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
20.0%
3/15 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
Respiratory rate increased
|
33.3%
3/9 • Number of events 5 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
48.1%
13/27 • Number of events 25 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
86.7%
13/15 • Number of events 21 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
73.3%
11/15 • Number of events 19 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
White blood cell count increased
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Investigations
White blood cells urine positive
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
14.8%
4/27 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
33.3%
5/15 • Number of events 6 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
25.0%
2/8 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
14.8%
4/27 • Number of events 7 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
13.3%
2/15 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
26.7%
4/15 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
12.5%
1/8 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
16.7%
4/24 • Number of events 4 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
3.7%
1/27 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/24 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
7.4%
2/27 • Number of events 3 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
6.7%
1/15 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
8.3%
2/24 • Number of events 2 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/9 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/27 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/15 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
0.00%
0/8 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
4.2%
1/24 • Number of events 1 • 10 months
Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place