Trial Outcomes & Findings for Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function (NCT NCT03718533)
NCT ID: NCT03718533
Last Updated: 2024-02-29
Results Overview
Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) by Week 16. PR was defined when any of the following: Platelet count ≥ 20000/microliter(μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was \<1000/μL) and/or hemoglobin (Hb) ≥100 gram(g)/ liter(L) (when pretreatment Hb was \<100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was \<1000/μL) and Hb ≥110 g/L (when pretreatment Hb was \<100g/L), confirmed in two blood tests separated a minimum of 7 days. Participants who discontinued before Week 16 were considered as responders if, in the last evaluation, they had PR or CR. The 95% Confidence Interval (CI) was the binomial exact CI based on Clopper-Pearson method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline up to Week 16
Results posted on
2024-02-29
Participant Flow
The study was conducted across 7 centers in 1 country (Spain).
A total of 25 participants were screened in this study of which 15 failed screening and 10 participants were enrolled in the study.
Participant milestones
| Measure |
Eltrombopag
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Eltrombopag
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Overall Study
Myelodysplastic syndrome and study indication
|
1
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Relapse
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Physician Decision and Adverse Event
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function
Baseline characteristics by cohort
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Age, Continuous
|
52.5 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: All participants to whom study treatment was assigned.
Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) by Week 16. PR was defined when any of the following: Platelet count ≥ 20000/microliter(μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was \<1000/μL) and/or hemoglobin (Hb) ≥100 gram(g)/ liter(L) (when pretreatment Hb was \<100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was \<1000/μL) and Hb ≥110 g/L (when pretreatment Hb was \<100g/L), confirmed in two blood tests separated a minimum of 7 days. Participants who discontinued before Week 16 were considered as responders if, in the last evaluation, they had PR or CR. The 95% Confidence Interval (CI) was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 30 and 36Population: All participants to whom study treatment was assigned and pretreatment ANC was \<1000 µL. Number analyzed signified number of participants that reached the study week.
Percentage of participants who had a response (partial or complete) in the neutrophil lineage. A partial response in the neutrophil lineage was defined as absolute neutrophil count (ANC) ≥1000/ µL (when pretreatment ANC was \<1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the neutrophil lineage was defined as ANC ≥ 1500/ µL (when pretreatment ANC was \<1000/μL) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method
Outcome measures
| Measure |
Eltrombopag
n=4 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Had a Response in the Neutrophil Lineage
Week 16
|
100 Percentage of Participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=1) had a response
|
|
Percentage of Participants Who Had a Response in the Neutrophil Lineage
Week 20
|
100 Percentage of Participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=1) had a response
|
|
Percentage of Participants Who Had a Response in the Neutrophil Lineage
Week 24
|
100 Percentage of Participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=1) had a response
|
|
Percentage of Participants Who Had a Response in the Neutrophil Lineage
Week 30
|
100 Percentage of Participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=1) had a response
|
|
Percentage of Participants Who Had a Response in the Neutrophil Lineage
Week 36
|
100 Percentage of Participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=1) had a response
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 30 and 36Population: All participants to whom study treatment was assigned. Number analyzed signified number of participants that reached the study week.
Percentage of participants who had a response (partial or complete) in the platelet lineage. A partial response in the platelet lineage was defined as platelet count ≥20000/µL (with platelet transfusion independence) confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the platelet lineage was defined as platelet count ≥ 100000/µL confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Had a Response in the Platelet Lineage
Week 16
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Who Had a Response in the Platelet Lineage
Week 20
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
|
Percentage of Participants Who Had a Response in the Platelet Lineage
Week 24
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
|
Percentage of Participants Who Had a Response in the Platelet Lineage
Week 30
|
100 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=5) had a response
|
|
Percentage of Participants Who Had a Response in the Platelet Lineage
Week 36
|
100 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=3) had a response
|
SECONDARY outcome
Timeframe: Week 16, 20, 24, 30 and 36Population: All participants to whom study treatment was assigned and pretreatment Hb \<100g/L. Number analyzed signified number of participants that reached the study week.
Percentage of participants who had a response (partial or complete) in the hemoglobin (Hb) lineage. A partial response in the Hb lineage was defined as Hb ≥100 g/L (when pretreatment Hb was \<100g/L) (with RBC transfusion independence), confirmed in two consecutive blood tests separated a minimum of 7 days. A complete response in the Hb lineage was defined as Hb≥ 110 g/L (when pretreatment Hb was \<100g/L) confirmed in two consecutive blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=6 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Had a Response in the Hemoglobin Lineage
Week 16
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
|
Percentage of Participants Who Had a Response in the Hemoglobin Lineage
Week 20
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
|
Percentage of Participants Who Had a Response in the Hemoglobin Lineage
Week 24
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
|
Percentage of Participants Who Had a Response in the Hemoglobin Lineage
Week 30
|
100 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=4) had a response
|
|
Percentage of Participants Who Had a Response in the Hemoglobin Lineage
Week 36
|
100 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=2) had a response
|
SECONDARY outcome
Timeframe: Week 24 and 36Population: All participants to whom study treatment was assigned. Number analyzed signified number of participants that reached the study week.
Hematologic response rate was defined as the percentage of participants who met the criteria of either complete response (CR) or partial response (PR) at 24 weeks and 36 weeks after the initiation of eltrombopag. PR was defined when any of the following: Platelet count ≥20000/microliter (μL) (with platelet transfusion independence), absolute neutrophil count (ANC) ≥1000/μL (when pretreatment ANC was \<1000/μL) and/or hemoglobin (Hb) ≥100 gram (g)/ liter (L) (when pretreatment Hb was \<100g/L) (with red blood cells transfusion independence), confirmed in two blood tests separated a minimum of 7 days. CR was defined when all three of the following: platelet count ≥100000/μL, ANC ≥1500/μL (when pretreatment ANC was \<1000/μL) and Hb ≥110 g/L (when pretreatment Hb was \<100g/L), confirmed in two blood tests separated a minimum of 7 days. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Hematologic Response Rate at Week 24 and 36
Week 24
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
|
Hematologic Response Rate at Week 24 and 36
Week 36
|
100 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated as all participants analyzed (n=3) had a response
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment, assessed up to 36 weeksPopulation: All participants to whom study treatment was assigned and who received at least one platelet transfusion before starting treatment. Number analyzed signified number of participants with evaluable data for this outcome measure at specified time points
Percentage of participants who received at least one platelet transfusion before starting treatment and who did no longer require platelet transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=7 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Were Previously Platelet Transfusion-dependent and Did no Longer Require Platelet Transfusions After the Initiation of Eltrombopag
From start of treatment to Week 16
|
0 Percentage of participants
Not Applicable (NA) indicates confidence interval could not be calculated as no participants had platelet transfusion independence during this period
|
|
Percentage of Participants Who Were Previously Platelet Transfusion-dependent and Did no Longer Require Platelet Transfusions After the Initiation of Eltrombopag
From Week 16 to end of treatment
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment, assessed up to 36 weeksPopulation: All participants to whom study treatment was assigned and who received at least one red blood cells transfusion before starting treatment. Number analyzed signified number of participants with evaluable data for this outcome measure at specified time points
Percentage of participants who received at least one red blood cells transfusion before starting treatment and who did no longer require red blood cells transfusion before and after the first 16 weeks of treatment. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=6 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Were Previously Red Blood Cells Transfusion-dependent and Did no Longer Require Red Blood Cells Transfusions
From start of treatment to Week 16
|
16.7 Percentage of participants
Interval 0.42 to 64.1
|
|
Percentage of Participants Who Were Previously Red Blood Cells Transfusion-dependent and Did no Longer Require Red Blood Cells Transfusions
From Week 16 to end of treatment
|
50 Percentage of participants
Interval 1.2 to 98.7
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment, assessed up to 36 weeksPopulation: All participants to whom study treatment was assigned.
Duration of transfusion independence defined as the period of time where participants did not receive any platelet or red blood cells transfusions during the treatment period
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Duration of Transfusion Independence
|
137.7 Days
Standard Deviation 110.4
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment, assessed up to Week 36Population: All participants to whom study treatment was assigned with evaluable data for this outcome measure
Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant EPO therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=8 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Erythropoietin (EPO) Therapy
Discontinued EPO therapy
|
37.5 Percentage of participants
Interval 8.5 to 75.5
|
|
Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Erythropoietin (EPO) Therapy
Reduced by 50% EPO therapy
|
0 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated because no participants reduced by 50% EPO therapy
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment, assessed up to Week 36Population: All participants to whom study treatment was assigned with evaluable data for this outcome measure
Percentage of participants who discontinued or reduced by ≥50% from baseline the use of concomitant G-CSF therapy while receiving eltrombopag. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Outcome measures
| Measure |
Eltrombopag
n=7 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Granulocyte Colony-stimulating Factor (G-CSF) Therapy
Discontinued G-CSF therapy
|
85.7 Percentage of participants
Interval 42.1 to 99.7
|
|
Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Granulocyte Colony-stimulating Factor (G-CSF) Therapy
Reduced by 50% G-CSF therapy
|
0 Percentage of participants
Not applicable (NA) indicates confidence interval could not be calculated because no participants reduced by 50% G-CSF therapy
|
SECONDARY outcome
Timeframe: From start of treatment until the date of death, assessed up to 40 weeksPopulation: All participants to whom study treatment was assigned.
OS defined as the time from the date of inclusion until the date of death due to any cause was calculated using Kaplan-Meier estimated. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Overall Survival (OS)
|
NA Weeks
Standard Error NA
Not applicable (NA) indicates median OS was not reached
|
SECONDARY outcome
Timeframe: Week 24 and 36Population: All participants to whom study treatment was assigned.
Overall survival rate defined as the rate estimate of the percentage of participants who were alive at 24 and 36 weeks. All patients who discontinued from the study, regardless the reason of discontinuation, were followed for survival at Week 24 and 36, unless they withdrew their consent, died or were lost-to follow-up, in which case were censored at the last contact.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
Overall Survival Rate at 24 and 36 Weeks
Week 24
|
90.0 Percentage of participants
Interval 71.4 to 100.0
|
|
Overall Survival Rate at 24 and 36 Weeks
Week 36
|
80.0 Percentage of participants
Interval 52.5 to 100.0
|
POST_HOC outcome
Timeframe: On-treatment deaths: Up to 40 weeks. Post-treatment survival follow-up deaths: up to 40 weeksPopulation: All participants to whom study treatment was assigned.
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of eltrombopag. Post-treament survival follow-up deaths were collected from day 31 after last dose of study medication to end of study. Participants who completed treatment with study drug as planned at Week 36, were followed up until Week 40 and deaths that occurred within that time frame were counted as on-treatment. For all participants who discontinued from eltrombopag, post-treatment deaths due to any cause were collected after the on-treatment period until end of survival follow-up period.
Outcome measures
| Measure |
Eltrombopag
n=10 Participants
Participants received eltrombopag orally once daily up to 36 weeks.
|
|---|---|
|
All Collected Deaths
On-treatment deaths
|
0 Participants
|
|
All Collected Deaths
Post-treatment survival follow-up deaths
|
2 Participants
|
|
All Collected Deaths
All deaths
|
2 Participants
|
Adverse Events
Eltrombopag (On-treatment)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Eltrombopag (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Eltrombopag (On-treatment)
n=10 participants at risk
AEs during on-treatment period (up to 30 days post-treatment)
|
Eltrombopag (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Congenital, familial and genetic disorders
Chimerism
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 3 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
Other adverse events
| Measure |
Eltrombopag (On-treatment)
n=10 participants at risk
AEs during on-treatment period (up to 30 days post-treatment)
|
Eltrombopag (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
|
|---|---|---|
|
Reproductive system and breast disorders
Breast pain
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 5 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Asthenia
|
30.0%
3/10 • Number of events 3 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
10.0%
1/10 • Number of events 3 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Iron overload
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Surgical and medical procedures
Breast operation
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Cytomegalovirus infection
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Hypoglobulinaemia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Surgical and medical procedures
Papiloma excision
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 5 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Surgical and medical procedures
Finger amputation
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Number of events 2 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Urine analysis abnormal
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Eye disorders
Eye pruritus
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Investigations
Clostridium test positive
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to the last dose of study medication plus 30 days, up to 40 weeks. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to 40 weeks. These are not considered AEs
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
|
Additional Information
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER