Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients. (NCT NCT01598987)
NCT ID: NCT01598987
Last Updated: 2017-05-16
Results Overview
Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2017-05-16
Participant Flow
Overall 62 patients were screened prior to the data monitoring committee (DMC) recommendation to terminate enrolment. Six patients were screen failures. The other 56 patients were included and treated.
Participant milestones
| Measure |
Everolimus Based Regimen
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
|---|---|
|
Baseline to Month 12
STARTED
|
56
|
|
Baseline to Month 12
COMPLETED
|
50
|
|
Baseline to Month 12
NOT COMPLETED
|
6
|
|
Baseline to 24 Month
STARTED
|
56
|
|
Baseline to 24 Month
COMPLETED
|
48
|
|
Baseline to 24 Month
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Everolimus Based Regimen
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
|---|---|
|
Baseline to Month 12
Administrative problems
|
2
|
|
Baseline to Month 12
Withdrawal by Subject
|
4
|
|
Baseline to 24 Month
Withdrawal by Subject
|
5
|
|
Baseline to 24 Month
Administrative problems
|
2
|
|
Baseline to 24 Month
Lost to Follow-up
|
1
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
Baseline characteristics by cohort
| Measure |
Everolimus Based Regimen
n=56 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
|---|---|
|
Age, Continuous
|
4.9 years
STANDARD_DEVIATION 4.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set
Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.
Outcome measures
| Measure |
Everolimus Based Regimen
n=50 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
Growth percentile category
|
>25% - 50% Percentile
Growth percentile category
|
>50% - 75% Percentile
Growth percentile categpru
|
>75% - 95% Percentile
Growth percentile category
|
>95% Percentile
Growth percentile category
|
Total
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate - Month 12
|
6.2 mL/min/1.73m^2
Standard Deviation 19.52
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12-month and 24-month after start of study drugPopulation: Full Analysis Set
The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection\[tBPAR\], graft loss \[GL\] , death \[D\]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component. AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate.
Outcome measures
| Measure |
Everolimus Based Regimen
n=56 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
Growth percentile category
|
>25% - 50% Percentile
Growth percentile category
|
>50% - 75% Percentile
Growth percentile categpru
|
>75% - 95% Percentile
Growth percentile category
|
>95% Percentile
Growth percentile category
|
Total
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: tBPAR,GL,D,or loss to follow-up
|
1.9 Percentages
Interval 0.0 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: tBPAR,GL,or D
|
1.9 Percentages
Interval 0.0 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: Treated BPAR
|
1.9 Percentages
Interval 0.0 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: Graft loss
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: Death
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: Graft loss or death
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: BPAR
|
3.7 Percentages
Interval 0.4 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 12: Treated AR
|
3.6 Percentages
Interval 0.4 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: tBPAR,GL,or D
|
5.9 Percentages
Interval 0.3 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: tBPAR,GL,D,or loss to follow-up
|
9.7 Percentages
Interval 2.5 to 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: Treated BPAR
|
5.9 Percentages
Interval 0.3 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: Graft Loss
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: Death
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: Graft loss or death
|
0.0 Percentages
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: BPAR
|
11.9 Percentages
Interval 4.2 to 19.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints
Month 24: Treated AR
|
7.7 Percentages
Interval 1.7 to 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full analysis set
Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.
Outcome measures
| Measure |
Everolimus Based Regimen
n=50 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
Growth percentile category
|
>25% - 50% Percentile
Growth percentile category
|
>50% - 75% Percentile
Growth percentile categpru
|
>75% - 95% Percentile
Growth percentile category
|
>95% Percentile
Growth percentile category
|
Total
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate - Month 24
|
4.5 mL/min/1.73m2
Standard Deviation 19.55
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Safety Analysis Set
Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (\<=5, \>5-25, \>25-50, \>50-75, \>75-95 and \>95% percentile).
Outcome measures
| Measure |
Everolimus Based Regimen
n=16 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
n=15 Participants
Growth percentile category
|
>25% - 50% Percentile
n=6 Participants
Growth percentile category
|
>50% - 75% Percentile
n=7 Participants
Growth percentile categpru
|
>75% - 95% Percentile
n=4 Participants
Growth percentile category
|
>95% Percentile
n=2 Participants
Growth percentile category
|
Total
n=50 Participants
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Growth Development - Height at Baseline and Month 12
Increase >5 to 10%
|
0.0 Percentages
|
20.0 Percentages
|
16.7 Percentages
|
14.3 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
10.0 Percentages
|
|
Growth Development - Height at Baseline and Month 12
Decrease
|
0.0 Percentages
|
26.7 Percentages
|
16.7 Percentages
|
14.3 Percentages
|
25.0 Percentages
|
0.0 Percentages
|
14.0 Percentages
|
|
Growth Development - Height at Baseline and Month 12
No Change
|
68.8 Percentages
|
20.0 Percentages
|
33.3 Percentages
|
28.6 Percentages
|
50.0 Percentages
|
100.0 Percentages
|
44.0 Percentages
|
|
Growth Development - Height at Baseline and Month 12
Increase >3 to 5%
|
12.5 Percentages
|
6.7 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
25.0 Percentages
|
0.0 Percentages
|
8.0 Percentages
|
|
Growth Development - Height at Baseline and Month 12
Increase >10%
|
18.8 Percentages
|
26.7 Percentages
|
33.3 Percentages
|
42.9 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
24.0 Percentages
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Safety Analysis Set
Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (\<=5, \>5-25, \>25-50, \>50-75, \>75-95 and \>95% percentile).
Outcome measures
| Measure |
Everolimus Based Regimen
n=15 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
n=10 Participants
Growth percentile category
|
>25% - 50% Percentile
n=7 Participants
Growth percentile category
|
>50% - 75% Percentile
n=11 Participants
Growth percentile categpru
|
>75% - 95% Percentile
n=6 Participants
Growth percentile category
|
>95% Percentile
n=1 Participants
Growth percentile category
|
Total
n=50 Participants
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Growth Development - Weight at Baseline and Month 12
No Change
|
33.3 Percentages
|
20.0 Percentages
|
0.0 Percentages
|
18.2 Percentages
|
33.3 Percentages
|
100.0 Percentages
|
24.0 Percentages
|
|
Growth Development - Weight at Baseline and Month 12
Decrease
|
0.0 Percentages
|
20.0 Percentages
|
42.9 Percentages
|
72.7 Percentages
|
16.7 Percentages
|
0.0 Percentages
|
28.0 Percentages
|
|
Growth Development - Weight at Baseline and Month 12
Increase >3 to 5%
|
0.0 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
16.7 Percentages
|
0.0 Percentages
|
2.0 Percentages
|
|
Growth Development - Weight at Baseline and Month 12
Increase >5 to 10%
|
26.7 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
9.1 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
10.0 Percentages
|
|
Growth Development - Weight at Baseline and Month 12
Increase >10%
|
40.0 Percentages
|
60.0 Percentages
|
57.1 Percentages
|
0.0 Percentages
|
33.3 Percentages
|
0.0 Percentages
|
36.0 Percentages
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Safety Analysis Set
Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (\<=5, \>5-25, \>25-50, \>50-75, \>75-95 and \>95% percentile).
Outcome measures
| Measure |
Everolimus Based Regimen
n=6 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
n=5 Participants
Growth percentile category
|
>25% - 50% Percentile
n=2 Participants
Growth percentile category
|
>50% - 75% Percentile
n=8 Participants
Growth percentile categpru
|
>75% - 95% Percentile
Growth percentile category
|
>95% Percentile
n=1 Participants
Growth percentile category
|
Total
n=22 Participants
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Growth Development - Weight at Baseline and Month 24
Increase >10%
|
16.7 Percentages
|
40.0 Percentages
|
0.0 Percentages
|
37.5 Percentages
|
—
|
0.0 Percentages
|
27.3 Percentages
|
|
Growth Development - Weight at Baseline and Month 24
Decrease
|
0.0 Percentages
|
40.0 Percentages
|
100.0 Percentages
|
12.5 Percentages
|
—
|
0.0 Percentages
|
22.7 Percentages
|
|
Growth Development - Weight at Baseline and Month 24
No Change
|
50.0 Percentages
|
0 Percentages
|
0.0 Percentages
|
25.0 Percentages
|
—
|
100.0 Percentages
|
27.3 Percentages
|
|
Growth Development - Weight at Baseline and Month 24
Increase >3 to 5%
|
16.7 Percentages
|
0 Percentages
|
0.0 Percentages
|
12.5 Percentages
|
—
|
0.0 Percentages
|
9.1 Percentages
|
|
Growth Development - Weight at Baseline and Month 24
Increase >5 to 10%
|
16.7 Percentages
|
20.0 Percentages
|
0.0 Percentages
|
12.5 Percentages
|
—
|
0.0 Percentages
|
13.6 Percentages
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Safety Analysis Set
Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (\<=5, \>5-25, \>25-50, \>50-75, \>75-95 and \>95% percentile).
Outcome measures
| Measure |
Everolimus Based Regimen
n=6 Participants
Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
|
>5% - 25% Percentile
n=8 Participants
Growth percentile category
|
>25% - 50% Percentile
n=3 Participants
Growth percentile category
|
>50% - 75% Percentile
n=2 Participants
Growth percentile categpru
|
>75% - 95% Percentile
n=2 Participants
Growth percentile category
|
>95% Percentile
n=1 Participants
Growth percentile category
|
Total
n=22 Participants
The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
|
|---|---|---|---|---|---|---|---|
|
Growth Development - Height at Baseline and Month 24
No Change
|
50.0 Percentages
|
12.5 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
50.0 Percentages
|
100.0 Percentages
|
27.3 Percentages
|
|
Growth Development - Height at Baseline and Month 24
Increase >5 to 10%
|
0.0 Percentages
|
0.0 Percentages
|
33.3 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
4.5 Percentages
|
|
Growth Development - Height at Baseline and Month 24
Increase >10%
|
16.7 Percentages
|
62.5 Percentages
|
33.3 Percentages
|
100.0 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
40.9 Percentages
|
|
Growth Development - Height at Baseline and Month 24
Decrease
|
0.0 Percentages
|
12.5 Percentages
|
33.3 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
9.00 Percentages
|
|
Growth Development - Height at Baseline and Month 24
Increase >3 to 5%
|
33.3 Percentages
|
12.5 Percentages
|
0.0 Percentages
|
0.0 Percentages
|
50.0 Percentages
|
0.0 Percentages
|
18.2 Percentages
|
Adverse Events
All Patients
Serious events: 43 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=56 participants at risk
All patients
|
|---|---|
|
Infections and infestations
Enteritis infectious
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Splenic lesion
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Internal hernia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
Chest pain
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
General physical health deterioration
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
Pyrexia
|
16.1%
9/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Cholangitis
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Hepatic vein occlusion
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Hepatobiliary disorders
Portal fibrosis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Immune system disorders
Food allergy
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Immune system disorders
Transplant rejection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Adenovirus infection
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Bacterial pyelonephritis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Catheter site infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Cholangitis infective
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Clostridium difficile infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Croup infectious
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Diarrhoea infectious
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Ear infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Enterovirus infection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Epstein-Barr viraemia
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Epstein-Barr virus infection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Escherichia infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastroenteritis
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastroenteritis sapovirus
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastrointestinal infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Infection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Mastoiditis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Oral candidiasis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Oral viral infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Otitis media
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Paronychia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Pneumonia
|
12.5%
7/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Puncture site infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Respiratory tract infection
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Rhinovirus infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Rotavirus infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Scarlet fever
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Sepsis
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Staphylococcal infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Tonsillitis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Varicella zoster virus infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Viral infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Wound infection
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Blood creatinine increased
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Body temperature increased
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
C-reactive protein increased
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Drug level increased
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Hepatic enzyme increased
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Liver function test increased
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Weight decreased
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Psychiatric disorders
Food aversion
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
2/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.8%
1/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
Other adverse events
| Measure |
All Patients
n=56 participants at risk
All patients
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Ear and labyrinth disorders
Ear pain
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
7/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
39.3%
22/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Mouth ulceration
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
15/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
Fatigue
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
Pain
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
General disorders
Pyrexia
|
39.3%
22/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Bronchitis
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Conjunctivitis
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Diarrhoea infectious
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Ear infection
|
10.7%
6/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Epstein-Barr viraemia
|
17.9%
10/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Epstein-Barr virus infection
|
12.5%
7/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Eye infection
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Gastroenteritis
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Influenza
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Nasopharyngitis
|
26.8%
15/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Otitis media
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Rhinitis
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Tonsillitis
|
8.9%
5/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
14/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
7/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Investigations
Hepatic enzyme increased
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Nervous system disorders
Headache
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
7/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
4/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Day 1 to month 24.
The incidence of AEs (including infections), by primary preferred terms sorted by system organ class were collected on Day 1 and last day with study medication plus 7 days.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER