Trial Outcomes & Findings for Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19 (NCT NCT05124210)
NCT ID: NCT05124210
Last Updated: 2024-01-03
Results Overview
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.
TERMINATED
PHASE2
8 participants
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
2024-01-03
Participant Flow
Total of 8 participants were enrolled in this study. Four age bands were planned to be enrolled (12 to less than 18 years, 6 to less than 12 years, 2 to less than 6 years and Birth to less than 2 years). Due to early termination of the study, no participants were enrolled in the 2 to less than 6 years and birth to less than 2 years age bands.
This study was conducted in 2 cohorts (Cohort A and Cohort B). The study was terminated, due to a decrease in in-vitro neutralization of sotrovimab against circulating Omicron BA.2 SARS-CoV-2 variants. Hence, Cohort B was not initiated. None of the participants received Intramuscular (IM) administration of sotrovimab.
Participant milestones
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.7 YEARS
STANDARD_DEVIATION 0.58 • n=99 Participants
|
14.2 YEARS
STANDARD_DEVIATION 1.10 • n=107 Participants
|
12.5 YEARS
STANDARD_DEVIATION 2.51 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
|
0.05 Liter per day (L/day)
Geometric Coefficient of Variation 27.6
|
0.10 Liter per day (L/day)
Geometric Coefficient of Variation 28.5
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=1 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
|
342.96 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicate that data is not available since only one participant was analyzed. Therefore Geometric Coefficient of Variation was not derived.
|
191.67 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 29.45
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=1 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
|
0.000 Day
NA indicate that data is not available since only one participant was analyzed, the full range (minimum and maximum) were not derived.
|
0.003 Day
Interval 0.0 to 0.02
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab
|
6023.0 Day*microgram per milliliter (day*ug/mL)
Geometric Coefficient of Variation 7.91
|
4928.8 Day*microgram per milliliter (day*ug/mL)
Geometric Coefficient of Variation 24.4
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
|
37.5 Day
Geometric Coefficient of Variation 16.1
|
43.6 Day
Geometric Coefficient of Variation 22.0
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=1 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab
|
1.42 Liter
Geometric Coefficient of Variation NA
NA indicate that data is not available since only one participant was analyzed. Therefore Geometric Coefficient of Variation was not derived.
|
5.49 Liter
Geometric Coefficient of Variation 22.08
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=1 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Clearance (CL) Following Administration of Sotrovimab
|
42.62 milliliter per day (mL/day)
Geometric Coefficient of Variation NA
NA indicate that data is not available since only one participant was analyzed. Therefore Geometric Coefficient of Variation was not derived.
|
96.58 milliliter per day (mL/day)
Geometric Coefficient of Variation 30.44
|
PRIMARY outcome
Timeframe: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12Population: Due to early termination of the study, the Intramuscular (IM) administration cohort was not started. The bioavailability assessment was not performed between the Intravenous (IV) and Intramuscular (IM) administration of sotrovimab. Hence there is no data to report.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 29Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Participants with SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Participants with AE
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Participants with AESI
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 36Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
Participants with AESI
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
Participants with AE
|
1 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
Participants with SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
Progression of COVID-19 is defined as need for attended medical visit (including the visit to a hospital emergency room for management of illness or hospitalization for acute management of illness) or escalation to higher level of medical care or death.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Number of Participants With Progression of COVID-19 Through Day 29
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The analysis was performed on the Virology Set (Cohort A) that included all participants who are exposed to study treatment and have a quantifiable SARS-CoV-2 viral load measurement at baseline.
Severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29. For participants who required oxygen or respiratory support for premorbid conditions, disease progression was defined as any sustained (greater than \[\>\]24 hours) increase in the level or method of oxygen support required.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), at Day 5, Day 8 and Day 11Population: The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
The viral load change from baseline in nasal secretions was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) at Day 5, Day 8, and Day 11.
Outcome measures
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=2 Participants
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 Participants
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Day 8
|
-2.640 log10 copies per milliliter
Standard Deviation 0.6930
|
-2.398 log10 copies per milliliter
Standard Deviation 1.6272
|
|
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Day 11
|
-3.305 log10 copies per milliliter
Standard Deviation 0.2475
|
-2.870 log10 copies per milliliter
Standard Deviation 1.1430
|
|
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Baseline (Day 1)
|
5.085 log10 copies per milliliter
Standard Deviation 0.2475
|
4.712 log10 copies per milliliter
Standard Deviation 1.0668
|
|
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Day 5
|
-1.270 log10 copies per milliliter
Standard Deviation 2.6304
|
-2.160 log10 copies per milliliter
Standard Deviation 1.4053
|
Adverse Events
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)
n=3 participants at risk
Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)
n=5 participants at risk
Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
|
|---|---|---|
|
Congenital, familial and genetic disorders
Hypoplastic left heart syndrome
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Immune system disorders
Graft versus host disease
|
33.3%
1/3 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
0.00%
0/5 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Infections and infestations
Polyomavirus viraemia
|
33.3%
1/3 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
0.00%
0/5 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
0.00%
0/5 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
0.00%
0/5 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
0.00%
0/5 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Haematocrit increased
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
20.0%
1/5 • Number of events 1 • Upto Week 36
Safety Set comprised of all participants who are exposed to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER