Trial Outcomes & Findings for A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD (NCT NCT02956122)
NCT ID: NCT02956122
Last Updated: 2021-01-13
Results Overview
OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
TERMINATED
PHASE2/PHASE3
1 participants
Day 28
2021-01-13
Participant Flow
Study was conducted between 26 April 2017 (first participant first visit) and 03 May 2018 (last participant last visit).
A total of 1 participant was enrolled and completed Part 1 (GLASSIA) of the study, and was analyzed for efficacy and safety with individual PK parameters estimated. Part 2 (GLASSIA versus albumin \[control\]) was not initiated following discontinuation of the study due to operational and business considerations.
Participant milestones
| Measure |
GLASSIA
Participants received an intravenous (IV) infusion of GLASSIA at a dose of 90 milligrams per kilogram (mg/kg) on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 milligrams per kilogram per day (mg/kg/day) of methylprednisolone or equivalent steroid.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
Baseline characteristics by cohort
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.
OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Overall Response (OR) At Day 28
|
100 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.
GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (\<=) 50% of required calories; and reduction of stool volume by greater than or equal to (\>=) 50%, without ileus.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
|
100 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 56Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.
Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Overall Response at Day 56
|
100 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56 and 180Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.
Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (\<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (\>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: \>15 mg/dL.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of skin Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of skin Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of liver Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of liver Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of liver Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of liver Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of skin Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of skin Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of skin Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of GI Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of GI Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of GI Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of GI Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of GI Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of liver Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of liver Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of liver Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 28: Degree of liver Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of skin Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of skin Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of skin Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of skin Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of skin Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of GI Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of GI Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of GI Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of GI Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of GI Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of liver Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of liver Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of liver Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of liver Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 56: Degree of liver Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of skin Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of skin Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of skin Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of skin Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of skin Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of GI Involvement · Stage 0
|
1 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of GI Involvement · Stage 1
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of GI Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of GI Involvement · Stage 3
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of GI Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of liver Involvement · Stage 2
|
0 Participants
|
—
|
—
|
—
|
|
Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
Day 180: Degree of liver Involvement · Stage 4
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 180 and 365Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.
Incidence of chronic GvHD at Days 180 and 365 was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Incidence of Chronic Graft-versus-host Disease (GvHD)
Day 180
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Chronic Graft-versus-host Disease (GvHD)
Day 365
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 365Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable. Here, number of participants analyzed refer to the participants evaluable for this outcome.
OR was defined as GvHD CR + PR, defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. Duration of OR was not assessed due to the termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 365Population: Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable. Here, number of participants analyzed refer to the participants evaluable for this outcome.
GI response was defined as CR + PR, defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to \<= 50% of required calories; and reduction of stool volume by \>= 50%, without ileus. Duration of GI response was not assessed due to the termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 100, 180 and 365Population: Safety analysis (SAF) set consisted of all participants who received at least 1 dose of study treatment.
OS was defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
Day 100
|
NA Percentage of participants
No deaths were observed during the study.
|
—
|
—
|
—
|
|
Overall Survival (OS) - Percentage of Participants With an Event
Day 180
|
NA Percentage of participants
No deaths were observed during the study.
|
—
|
—
|
—
|
|
Overall Survival (OS) - Percentage of Participants With an Event
Day 365
|
NA Percentage of participants
No deaths were observed during the study.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56, 100 and 180Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant).
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Transplant-related Mortality
Day 28
|
0 Participants
|
—
|
—
|
—
|
|
Transplant-related Mortality
Day 56
|
0 Participants
|
—
|
—
|
—
|
|
Transplant-related Mortality
Day 100
|
0 Participants
|
—
|
—
|
—
|
|
Transplant-related Mortality
Day 180
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 100 and 180Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Failure-free Survival - Percentage of Participants With an Event
Day 100
|
100 Percentage of participants
|
—
|
—
|
—
|
|
Failure-free Survival - Percentage of Participants With an Event
Day 180
|
100 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56, 100, 180 and 365Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Day 365
|
100 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Day 28
|
100 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Day 56
|
100 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Day 100
|
100 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
Day 180
|
100 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56, 100 and 180Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Infection-related mortality was determined by the investigator (any deaths considered related to infection \[including infections related to hematopoietic stem cell transplant {HSCT}\]).
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Infection-related Mortality - Percentage of Participants With an Event
Day 28
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Infection-related Mortality - Percentage of Participants With an Event
Day 56
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Infection-related Mortality - Percentage of Participants With an Event
Day 100
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Infection-related Mortality - Percentage of Participants With an Event
Day180
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56, 100 and 180Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD).
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Day 28
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Day 56
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Day 100
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
Day 180
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28, 56, 100 and 180Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
All-cause mortality was defined as the time from HSCT to death due to any cause.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
All-cause Mortality - Percentage of Participants With an Event
Day 28
|
0 Percentage of participants
|
—
|
—
|
—
|
|
All-cause Mortality - Percentage of Participants With an Event
Day 56
|
0 Percentage of participants
|
—
|
—
|
—
|
|
All-cause Mortality - Percentage of Participants With an Event
Day 100
|
0 Percentage of participants
|
—
|
—
|
—
|
|
All-cause Mortality - Percentage of Participants With an Event
Day180
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 371 daysPopulation: SAF set consisted of all participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome was fatal/results in death, life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Any Adverse Event
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Treatment-related AEs
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Serious adverse Events (SAEs)
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Treatment-related SAEs
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
Temporally-associated AEs
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 56Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 56Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 365Population: SAF set consisted of all participants who received at least 1 dose of study treatment.
Incidence of recurrence of primary malignancies was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Number of Participants With Recurrence of Primary Malignancies
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
AUC of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
|
61500 Hour*milligrams per deciliter (h*mg/dL)
|
43500 Hour*milligrams per deciliter (h*mg/dL)
|
126000 Hour*milligrams per deciliter (h*mg/dL)
|
117000 Hour*milligrams per deciliter (h*mg/dL)
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
AUC(0-t) of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time Zero to Time "t" AUC(0-t) of GLASSIA
|
16300 h*mg/dL
|
11000 h*mg/dL
|
40400 h*mg/dL
|
33400 h*mg/dL
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
CLss of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Systemic Clearance at Steady State (CLss) of GLASSIA
|
0.297 Deciliters per hour (dL/h)
|
0.286 Deciliters per hour (dL/h)
|
0.260 Deciliters per hour (dL/h)
|
—
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
Cmax of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GLASSIA
|
339 Milligrams per deciliter (mg/dl)
|
262 Milligrams per deciliter (mg/dl)
|
390 Milligrams per deciliter (mg/dl)
|
409 Milligrams per deciliter (mg/dl)
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
Vss of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
|
50.9 Deciliter (dL)
|
123 Deciliter (dL)
|
91.1 Deciliter (dL)
|
—
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.
Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported.
Outcome measures
| Measure |
GLASSIA
n=1 Participants
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
GLASSIA: Day 13: 30 mg/kg
n=1 Participants
Participants received an IV infusion of 30 mg/kg GLASSIA.
|
GLASSIA: Day 22: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
GLASSIA: Day 50: 120 mg/kg
n=1 Participants
Participants received an IV infusion of 120 mg/kg GLASSIA.
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of GLASSIA
|
152 Hour (h)
|
117 Hour (h)
|
317 Hour (h)
|
247 Hour (h)
|
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected. Her, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
MRT of GLASSIA was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hoursPopulation: PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected. Here, number of participants analyzed refer to the participants evaluable for this outcome at specified time point.
Ctrough of GLASSIA was not assessed due to the termination of the study.
Outcome measures
Outcome data not reported
Adverse Events
GLASSIA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLASSIA
n=1 participants at risk
Participants received an IV infusion of GLASSIA at a dose of 90 mg/kg on Day 1 followed by 30 mg/kg every other day (Days 3 to 13), then followed by 120 mg/kg weekly (Days 15 to 50) along with 2 mg/kg/day of methylprednisolone or equivalent steroid.
|
|---|---|
|
Investigations
Platelet count decreased/
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
1/1 • Number of events 6 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Eye disorders
Vision blurred
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Investigations
Weight decreased
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Investigations
Blood cholesterol increased
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Infections and infestations
Sinusitis
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Vascular disorders
Hot flush
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Investigations
White blood cell count decreased
|
100.0%
1/1 • Number of events 3 • From the start of drug administration up to 371 days
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Gastrointestinal disorders
Toothache
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Infections and infestations
Mucosal infection
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
General disorders
Localised oedema
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Infections and infestations
Cellulitis
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Nervous system disorders
Amnesia
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Investigations
Bilirubin conjugated increased
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Number of events 2 • From the start of drug administration up to 371 days
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Gastrointestinal disorders
Tongue ulceration
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
100.0%
1/1 • Number of events 1 • From the start of drug administration up to 371 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonmentor termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER