Trial Outcomes & Findings for Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients (NCT NCT00952380)
NCT ID: NCT00952380
Last Updated: 2019-04-16
Results Overview
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
4 hours post-dose at each Day 1 to 7 in dose adjustment phase
Results posted on
2019-04-16
Participant Flow
The study was conducted in the 5 countries from 20 August 2009 to 20 March 2018. A total of 38 participants were enrolled. This study had dose adjustment (DA) phase (Day 1-7), pharmacodynamic (PD) phase (Day 8-14) and follow up (FU) phase (Day 15-104).
Participant milestones
| Measure |
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
Participants aged greater than or equal to (\>=) 0 to less than (\<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
8
|
7
|
20
|
|
Overall Study
COMPLETED
|
1
|
1
|
6
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
Participants aged greater than or equal to (\>=) 0 to less than (\<) 8 weeks were administered 125 international unit per kilogram (IU/kg) of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying venous thromboembolism (VTE). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Non-compliant to protocol
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Baseline characteristics by cohort
| Measure |
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
n=1 Participants
Participants aged \>= 0 to \< 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
0.0684 years
n=5 Participants
|
1.0569 years
n=7 Participants
|
5.3676 years
n=5 Participants
|
10.0287 years
n=4 Participants
|
15.7208 years
n=21 Participants
|
11.1577 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=34 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
|
125 IU/mL
Interval 99.1 to 213.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 in dose adjustment phasePopulation: Analysis population included all the participants who received at least 1 dose of study drug.
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
|
0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
100.0 percentage of participants
Interval 63.06 to 100.0
|
100.0 percentage of participants
Interval 59.04 to 100.0
|
85.0 percentage of participants
Interval 62.11 to 96.79
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this outcome measure (OM) was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.
It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=34 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
|
NA days
Median and 95% CI was not estimable due to the low number of participants who had VTE.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
No Change
|
0 percentage of participants
Interval 0.0 to 84.19
|
0 percentage of participants
Interval 0.0 to 36.94
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
5.9 percentage of participants
Interval 0.15 to 28.69
|
—
|
|
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Progression
|
0 percentage of participants
Interval 0.0 to 84.19
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
0 percentage of participants
Interval 0.0 to 19.51
|
—
|
|
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Regression
|
0 percentage of participants
Interval 0.0 to 84.19
|
12.5 percentage of participants
Interval 0.32 to 52.65
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
29.4 percentage of participants
Interval 10.31 to 55.96
|
—
|
|
Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)
Resolution
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
62.5 percentage of participants
Interval 24.49 to 91.48
|
57.1 percentage of participants
Interval 18.41 to 90.1
|
58.8 percentage of participants
Interval 32.92 to 81.56
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The safety analysis set included all the participants who received at least 1 dose of study drug.
A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding).
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Major and Minor Bleeding Event
Major Bleeding
|
0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 1.26 to 98.74
|
0 percentage of participants
Interval 0.0 to 36.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
0 percentage of participants
Interval 0.0 to 16.84
|
|
Percentage of Participants With Major and Minor Bleeding Event
Minor Bleeding
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 84.19
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
57.1 percentage of participants
Interval 18.41 to 90.1
|
40.0 percentage of participants
Interval 19.12 to 63.95
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The safety analysis set included all the participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
1 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
19 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 104 daysPopulation: The safety analysis set included all the participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(\<)0.8\*lower limit of normal(LLN), platelets \<0.5\*LLN \>1.75\*upper limit of normal (ULN),leukocytes \<0.6\* LLN \>1.5\* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes \<0.8\* LLN \>1.2\* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes \>1.2\*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio \>1.1\* ULN. Clinical chemistry: bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN, protein, albumin \<0.8\* LLN \>1.2\* ULN, blood urea nitrogen, creatinine \>1.3\* ULN, sodium \<0.95\*LLN \>1.05\*ULN, potassium, chloride, calcium, magnesium \<0.9\* LLN \>1.1\* ULN, phosphate \<0.8\* LLN \>1.2\* ULN, glucose \<0.6\*LLN \>1.5\*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, \>1.0\* ULN. Urinalysis: creatinine \>1.0\*ULN.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=19 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
1 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Day 60
|
51.00 millimeters of mercury (mmHg)
Interval 51.0 to 51.0
|
57.00 millimeters of mercury (mmHg)
Interval 57.0 to 57.0
|
60.00 millimeters of mercury (mmHg)
Interval 46.0 to 73.0
|
67.00 millimeters of mercury (mmHg)
Interval 59.0 to 70.0
|
67.00 millimeters of mercury (mmHg)
Interval 57.0 to 80.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Baseline
|
101.00 millimeters of mercury (mmHg)
Interval 101.0 to 101.0
|
50.00 millimeters of mercury (mmHg)
Interval 50.0 to 50.0
|
110.50 millimeters of mercury (mmHg)
Interval 95.0 to 119.0
|
96.00 millimeters of mercury (mmHg)
Interval 94.0 to 119.0
|
117.50 millimeters of mercury (mmHg)
Interval 97.0 to 140.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Day 1
|
97.00 millimeters of mercury (mmHg)
Interval 97.0 to 97.0
|
105.50 millimeters of mercury (mmHg)
Interval 63.0 to 148.0
|
112.0 millimeters of mercury (mmHg)
Interval 100.0 to 137.0
|
111.00 millimeters of mercury (mmHg)
Interval 100.0 to 126.0
|
113.00 millimeters of mercury (mmHg)
Interval 92.0 to 130.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Day 2
|
94.00 millimeters of mercury (mmHg)
Interval 94.0 to 94.0
|
75.00 millimeters of mercury (mmHg)
Interval 75.0 to 75.0
|
107.00 millimeters of mercury (mmHg)
Interval 90.0 to 128.0
|
112.00 millimeters of mercury (mmHg)
Interval 101.0 to 126.0
|
119.50 millimeters of mercury (mmHg)
Interval 98.0 to 158.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Day 30
|
77.0 millimeters of mercury (mmHg)
Interval 77.0 to 77.0
|
77.00 millimeters of mercury (mmHg)
Interval 77.0 to 77.0
|
112.00 millimeters of mercury (mmHg)
Interval 100.0 to 123.0
|
109.00 millimeters of mercury (mmHg)
Interval 100.0 to 113.0
|
118.00 millimeters of mercury (mmHg)
Interval 95.0 to 133.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Day 60
|
74.00 millimeters of mercury (mmHg)
Interval 74.0 to 74.0
|
102.00 millimeters of mercury (mmHg)
Interval 102.0 to 102.0
|
101.00 millimeters of mercury (mmHg)
Interval 91.0 to 124.0
|
118.00 millimeters of mercury (mmHg)
Interval 102.0 to 130.0
|
117.50 millimeters of mercury (mmHg)
Interval 102.0 to 134.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
SBP: Day 90
|
76.00 millimeters of mercury (mmHg)
Interval 76.0 to 76.0
|
105.00 millimeters of mercury (mmHg)
Interval 93.0 to 117.0
|
97.50 millimeters of mercury (mmHg)
Interval 90.0 to 105.0
|
116.00 millimeters of mercury (mmHg)
Interval 99.0 to 123.0
|
116.00 millimeters of mercury (mmHg)
Interval 89.0 to 151.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Baseline
|
60.00 millimeters of mercury (mmHg)
Interval 60.0 to 60.0
|
41.00 millimeters of mercury (mmHg)
Interval 41.0 to 41.0
|
66.00 millimeters of mercury (mmHg)
Interval 50.0 to 77.0
|
67.00 millimeters of mercury (mmHg)
Interval 60.0 to 75.0
|
65.00 millimeters of mercury (mmHg)
Interval 46.0 to 80.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Day 1
|
61.00 millimeters of mercury (mmHg)
Interval 61.0 to 61.0
|
57.00 millimeters of mercury (mmHg)
Interval 41.0 to 73.0
|
65.50 millimeters of mercury (mmHg)
Interval 50.0 to 87.0
|
66.50 millimeters of mercury (mmHg)
Interval 54.0 to 81.0
|
64.00 millimeters of mercury (mmHg)
Interval 48.0 to 80.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Day 2
|
48.00 millimeters of mercury (mmHg)
Interval 48.0 to 48.0
|
53.00 millimeters of mercury (mmHg)
Interval 53.0 to 53.0
|
60.50 millimeters of mercury (mmHg)
Interval 53.0 to 70.0
|
70.00 millimeters of mercury (mmHg)
Interval 65.0 to 79.0
|
65.00 millimeters of mercury (mmHg)
Interval 53.0 to 95.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Day 30
|
53.00 millimeters of mercury (mmHg)
Interval 53.0 to 53.0
|
61.00 millimeters of mercury (mmHg)
Interval 61.0 to 61.0
|
64.00 millimeters of mercury (mmHg)
Interval 54.0 to 68.0
|
68.00 millimeters of mercury (mmHg)
Interval 53.0 to 71.0
|
69.00 millimeters of mercury (mmHg)
Interval 55.0 to 87.0
|
|
Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants
DSBP: Day 90
|
53.00 millimeters of mercury (mmHg)
Interval 53.0 to 53.0
|
55.50 millimeters of mercury (mmHg)
Interval 51.0 to 60.0
|
60.50 millimeters of mercury (mmHg)
Interval 52.0 to 70.0
|
67.00 millimeters of mercury (mmHg)
Interval 56.0 to 80.0
|
69.00 millimeters of mercury (mmHg)
Interval 59.0 to 95.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Heart rate and pulse rate of participants were measured in terms of beats per minute.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Baseline
|
148.00 beats per minute (bpm)
Interval 148.0 to 148.0
|
146.00 beats per minute (bpm)
Interval 146.0 to 146.0
|
115.00 beats per minute (bpm)
Interval 66.0 to 126.0
|
—
|
70.00 beats per minute (bpm)
Interval 52.0 to 84.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Day 1
|
146.00 beats per minute (bpm)
Interval 146.0 to 146.0
|
142.00 beats per minute (bpm)
Interval 142.0 to 142.0
|
112.00 beats per minute (bpm)
Interval 112.0 to 112.0
|
—
|
85.00 beats per minute (bpm)
Interval 46.0 to 139.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Day 2
|
136.00 beats per minute (bpm)
Interval 136.0 to 136.0
|
130.00 beats per minute (bpm)
Interval 130.0 to 130.0
|
114.00 beats per minute (bpm)
Interval 100.0 to 136.0
|
—
|
75.00 beats per minute (bpm)
Interval 56.0 to 124.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Day 30
|
138.00 beats per minute (bpm)
Interval 138.0 to 138.0
|
130.00 beats per minute (bpm)
Interval 130.0 to 130.0
|
120.50 beats per minute (bpm)
Interval 100.0 to 124.0
|
—
|
87.50 beats per minute (bpm)
Interval 56.0 to 126.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Day 60
|
132.00 beats per minute (bpm)
Interval 132.0 to 132.0
|
184.00 beats per minute (bpm)
Interval 184.0 to 184.0
|
120.00 beats per minute (bpm)
Interval 114.0 to 139.0
|
—
|
94.50 beats per minute (bpm)
Interval 56.0 to 134.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
HR: Day 90
|
122.00 beats per minute (bpm)
Interval 122.0 to 122.0
|
134.00 beats per minute (bpm)
Interval 134.0 to 134.0
|
107.00 beats per minute (bpm)
Interval 96.0 to 116.0
|
—
|
80.00 beats per minute (bpm)
Interval 66.0 to 118.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Baseline
|
—
|
—
|
96.50 beats per minute (bpm)
Interval 68.0 to 125.0
|
114.00 beats per minute (bpm)
Interval 80.0 to 119.0
|
73.00 beats per minute (bpm)
Interval 67.0 to 150.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Day 1
|
—
|
108.00 beats per minute (bpm)
Interval 108.0 to 108.0
|
121.00 beats per minute (bpm)
Interval 86.0 to 122.0
|
87.00 beats per minute (bpm)
Interval 76.0 to 120.0
|
94.50 beats per minute (bpm)
Interval 72.0 to 123.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Day 2
|
—
|
—
|
117.00 beats per minute (bpm)
Interval 113.0 to 138.0
|
98.00 beats per minute (bpm)
Interval 84.0 to 127.0
|
93.00 beats per minute (bpm)
Interval 57.0 to 161.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Day 30
|
—
|
—
|
88.00 beats per minute (bpm)
Interval 88.0 to 147.0
|
101.00 beats per minute (bpm)
Interval 90.0 to 150.0
|
102.00 beats per minute (bpm)
Interval 72.0 to 123.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Day 60
|
—
|
—
|
88.00 beats per minute (bpm)
Interval 88.0 to 99.0
|
93.00 beats per minute (bpm)
Interval 75.0 to 108.0
|
95.00 beats per minute (bpm)
Interval 62.0 to 117.0
|
|
Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants
PR: Day 90
|
—
|
140.00 beats per minute (bpm)
Interval 140.0 to 140.0
|
114.00 beats per minute (bpm)
Interval 113.0 to 120.0
|
96.00 beats per minute (bpm)
Interval 67.0 to 109.0
|
92.00 beats per minute (bpm)
Interval 74.0 to 124.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Height of Participants
Baseline
|
54.00 centimeters (cm)
Interval 54.0 to 54.0
|
55.00 centimeters (cm)
Interval 55.0 to 55.0
|
110.00 centimeters (cm)
Interval 98.0 to 125.5
|
133.00 centimeters (cm)
Interval 126.0 to 140.0
|
166.00 centimeters (cm)
Interval 142.0 to 178.0
|
|
Absolute Values of Height of Participants
Day 1
|
54.00 centimeters (cm)
Interval 54.0 to 54.0
|
—
|
115.80 centimeters (cm)
Interval 98.0 to 118.0
|
134.00 centimeters (cm)
Interval 126.0 to 142.0
|
166.00 centimeters (cm)
Interval 113.5 to 184.0
|
|
Absolute Values of Height of Participants
Day 2
|
—
|
—
|
107.90 centimeters (cm)
Interval 89.5 to 120.0
|
142.00 centimeters (cm)
Interval 126.0 to 159.9
|
166.90 centimeters (cm)
Interval 113.6 to 189.0
|
|
Absolute Values of Height of Participants
Day 30
|
60.00 centimeters (cm)
Interval 60.0 to 60.0
|
56.60 centimeters (cm)
Interval 56.6 to 56.6
|
115.10 centimeters (cm)
Interval 89.5 to 124.5
|
140.30 centimeters (cm)
Interval 128.0 to 159.9
|
167.75 centimeters (cm)
Interval 113.9 to 184.0
|
|
Absolute Values of Height of Participants
Day 60
|
63.00 centimeters (cm)
Interval 63.0 to 63.0
|
60.00 centimeters (cm)
Interval 60.0 to 60.0
|
115.00 centimeters (cm)
Interval 90.0 to 124.5
|
139.70 centimeters (cm)
Interval 128.0 to 161.6
|
168.50 centimeters (cm)
Interval 114.2 to 183.6
|
|
Absolute Values of Height of Participants
Day 90
|
64.00 centimeters (cm)
Interval 64.0 to 64.0
|
61.00 centimeters (cm)
Interval 61.0 to 61.0
|
109.50 centimeters (cm)
Interval 91.5 to 127.0
|
140.70 centimeters (cm)
Interval 129.0 to 161.6
|
166.65 centimeters (cm)
Interval 115.0 to 184.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Weight of Participants
Baseline
|
4.05 kilograms
Interval 4.05 to 4.05
|
3.93 kilograms
Interval 3.93 to 3.93
|
18.78 kilograms
Interval 12.8 to 34.7
|
36.60 kilograms
Interval 25.4 to 45.8
|
60.00 kilograms
Interval 48.0 to 86.9
|
|
Absolute Values of Weight of Participants
Day 1
|
4.17 kilograms
Interval 4.17 to 4.17
|
4.04 kilograms
Interval 4.04 to 4.04
|
17.23 kilograms
Interval 13.4 to 21.2
|
37.00 kilograms
Interval 25.4 to 40.6
|
63.40 kilograms
Interval 19.6 to 95.2
|
|
Absolute Values of Weight of Participants
Day 2
|
4.50 kilograms
Interval 4.5 to 4.5
|
4.15 kilograms
Interval 4.15 to 4.15
|
14.95 kilograms
Interval 11.9 to 34.7
|
39.35 kilograms
Interval 25.4 to 64.5
|
58.00 kilograms
Interval 19.7 to 89.8
|
|
Absolute Values of Weight of Participants
Day 30
|
6.30 kilograms
Interval 6.3 to 6.3
|
4.56 kilograms
Interval 4.56 to 4.56
|
15.50 kilograms
Interval 13.0 to 37.2
|
39.20 kilograms
Interval 23.0 to 64.5
|
63.80 kilograms
Interval 21.8 to 91.7
|
|
Absolute Values of Weight of Participants
Day 60
|
7.15 kilograms
Interval 7.15 to 7.15
|
4.60 kilograms
Interval 4.6 to 4.6
|
16.60 kilograms
Interval 12.7 to 37.2
|
38.30 kilograms
Interval 24.1 to 68.6
|
65.80 kilograms
Interval 22.7 to 90.8
|
|
Absolute Values of Weight of Participants
Day 90
|
7.70 kilograms
Interval 7.7 to 7.7
|
4.70 kilograms
Interval 4.7 to 4.7
|
21.50 kilograms
Interval 14.0 to 38.5
|
39.30 kilograms
Interval 24.4 to 68.6
|
59.60 kilograms
Interval 22.6 to 89.8
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Respiratory rate was defined as the number of breaths per minute.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Respiratory Rate of Participants
Baseline
|
35.00 breaths per minute
Interval 35.0 to 35.0
|
25.00 breaths per minute
Interval 25.0 to 25.0
|
24.00 breaths per minute
Interval 18.0 to 24.0
|
20.00 breaths per minute
Interval 18.0 to 30.0
|
20.00 breaths per minute
Interval 17.0 to 36.0
|
|
Absolute Values of Respiratory Rate of Participants
Day 1
|
34.00 breaths per minute
Interval 34.0 to 34.0
|
36.00 breaths per minute
Interval 36.0 to 36.0
|
21.00 breaths per minute
Interval 20.0 to 24.0
|
18.00 breaths per minute
Interval 16.0 to 20.0
|
18.00 breaths per minute
Interval 16.0 to 30.0
|
|
Absolute Values of Respiratory Rate of Participants
Day 2
|
34.00 breaths per minute
Interval 34.0 to 34.0
|
34.00 breaths per minute
Interval 34.0 to 34.0
|
20.00 breaths per minute
Interval 18.0 to 24.0
|
20.00 breaths per minute
Interval 18.0 to 24.0
|
18.00 breaths per minute
Interval 16.0 to 24.0
|
|
Absolute Values of Respiratory Rate of Participants
Day 30
|
34.00 breaths per minute
Interval 34.0 to 34.0
|
36.00 breaths per minute
Interval 36.0 to 36.0
|
22.00 breaths per minute
Interval 16.0 to 28.0
|
22.00 breaths per minute
Interval 20.0 to 24.0
|
18.00 breaths per minute
Interval 16.0 to 32.0
|
|
Absolute Values of Respiratory Rate of Participants
Day 60
|
30.00 breaths per minute
Interval 30.0 to 30.0
|
36.00 breaths per minute
Interval 36.0 to 36.0
|
20.00 breaths per minute
Interval 16.0 to 24.0
|
20.00 breaths per minute
Interval 18.0 to 20.0
|
20.00 breaths per minute
Interval 16.0 to 30.0
|
|
Absolute Values of Respiratory Rate of Participants
Day 90
|
24.00 breaths per minute
Interval 24.0 to 24.0
|
34.00 breaths per minute
Interval 32.0 to 36.0
|
22.00 breaths per minute
Interval 20.0 to 24.0
|
20.00 breaths per minute
Interval 18.0 to 22.0
|
18.00 breaths per minute
Interval 12.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Body Temperature of Participants
Baseline
|
36.60 degree celsius
Interval 36.6 to 36.6
|
36.70 degree celsius
Interval 36.7 to 36.7
|
36.50 degree celsius
Interval 36.1 to 37.3
|
37.00 degree celsius
Interval 36.2 to 37.2
|
36.80 degree celsius
Interval 35.6 to 39.3
|
|
Absolute Values of Body Temperature of Participants
Day 1
|
36.70 degree celsius
Interval 36.7 to 36.7
|
36.85 degree celsius
Interval 36.7 to 37.0
|
36.80 degree celsius
Interval 36.7 to 36.9
|
36.70 degree celsius
Interval 36.0 to 37.0
|
36.80 degree celsius
Interval 36.1 to 37.1
|
|
Absolute Values of Body Temperature of Participants
Day 2
|
36.90 degree celsius
Interval 36.9 to 36.9
|
36.40 degree celsius
Interval 36.4 to 36.4
|
36.70 degree celsius
Interval 35.3 to 37.3
|
36.70 degree celsius
Interval 36.6 to 36.8
|
36.70 degree celsius
Interval 36.4 to 37.7
|
|
Absolute Values of Body Temperature of Participants
Day 30
|
36.50 degree celsius
Interval 36.5 to 36.5
|
36.50 degree celsius
Interval 36.5 to 36.5
|
36.60 degree celsius
Interval 35.5 to 37.3
|
36.50 degree celsius
Interval 36.4 to 38.6
|
36.70 degree celsius
Interval 35.1 to 37.1
|
|
Absolute Values of Body Temperature of Participants
Day 60
|
36.60 degree celsius
Interval 36.6 to 36.6
|
36.70 degree celsius
Interval 36.7 to 36.7
|
36.80 degree celsius
Interval 36.4 to 38.6
|
36.60 degree celsius
Interval 35.6 to 36.9
|
36.60 degree celsius
Interval 35.7 to 37.0
|
|
Absolute Values of Body Temperature of Participants
Day 90
|
36.70 degree celsius
Interval 36.7 to 36.7
|
37.15 degree celsius
Interval 36.7 to 37.6
|
36.75 degree celsius
Interval 35.9 to 37.5
|
36.90 degree celsius
Interval 36.7 to 38.4
|
36.80 degree celsius
Interval 36.1 to 38.4
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 30, Day 60, Day 90Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Absolute Values of Body Length of Participants
Day 30
|
60 centimeter
Interval 60.0 to 60.0
|
56.60 centimeter
Interval 56.6 to 56.6
|
100 centimeter
Interval 89.5 to 124.5
|
—
|
135 centimeter
Interval 135.0 to 135.0
|
|
Absolute Values of Body Length of Participants
Baseline
|
54 centimeter
Interval 54.0 to 54.0
|
55 centimeter
Interval 55.0 to 55.0
|
100 centimeter
Interval 100.0 to 100.0
|
—
|
172 centimeter
Interval 172.0 to 172.0
|
|
Absolute Values of Body Length of Participants
Day 1
|
54 centimeter
Interval 54.0 to 54.0
|
55 centimeter
Interval 55.0 to 55.0
|
—
|
—
|
135 centimeter
Interval 135.0 to 135.0
|
|
Absolute Values of Body Length of Participants
Day 2
|
56 centimeter
Interval 56.0 to 56.0
|
55.30 centimeter
Interval 55.3 to 55.3
|
104.75 centimeter
Interval 89.5 to 120.0
|
—
|
135 centimeter
Interval 135.0 to 135.0
|
|
Absolute Values of Body Length of Participants
Day 60
|
63 centimeter
Interval 63.0 to 63.0
|
60 centimeter
Interval 60.0 to 60.0
|
103 centimeter
Interval 90.0 to 124.5
|
—
|
135 centimeter
Interval 135.0 to 135.0
|
|
Absolute Values of Body Length of Participants
Day 90
|
64 centimeter
Interval 64.0 to 64.0
|
61 centimeter
Interval 61.0 to 61.0
|
97.75 centimeter
Interval 91.5 to 104.0
|
—
|
151.75 centimeter
Interval 135.0 to 168.5
|
SECONDARY outcome
Timeframe: Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)Population: The safety analysis set included all the participants who received at least 1 dose of study drug. Here "number analyzed" signifies the number of participants evaluable at specific time points.
Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=1 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 Participants
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Screening
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 2
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 4
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Abdomen: Visit 7
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 2
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Chest: Visit 7
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 3
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Extremities: Visit 7
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes: Visit 7
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat:Screening
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat: Visit 3
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat: Visit 4
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat: Visit 5
|
—
|
—
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat: Visit 6
|
—
|
—
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Eyes, ears, nose, throat: Visit 7
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Screening
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
General appearance: Visit 7
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Visit 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Visit 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Visit 5
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Visit 6
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Head: Visit 7
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Heart: Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Heart: Visit 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Heart: Visit 4
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Heart: Visit 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Lungs: Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Lungs: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Lungs: Visit 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Lungs: Visit 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neck: Screening
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neck: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Screening
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Visit 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Visit 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Neurological: Visit 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Nose: Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Nose: Visit 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Screening
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 3
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 4
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 5
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Physical Examination Abnormalities of Participants
Skin: Visit 7
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug (up to Day 132)Population: The safety analysis set included all the participants who received at least 1 dose of study drug.
Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal).
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=38 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Time to First Occurrence of Major Bleeding Event
|
NA days
Median and 95% CI was not estimable due to the low number of participants who had bleeding episodes.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 30, Day 60, Day 90 in follow up phasePopulation: PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, "number analyzed" signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Day 30
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
—
|
|
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Day 60
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
75.0 percentage of participants
Interval 19.41 to 99.37
|
81.8 percentage of participants
Interval 48.22 to 97.72
|
—
|
|
Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase
Day 90
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 39.76 to 100.0
|
50.0 percentage of participants
Interval 1.26 to 98.74
|
72.7 percentage of participants
Interval 39.03 to 93.98
|
—
|
SECONDARY outcome
Timeframe: Day 30, Day 60, Day 90 in follow-up phasePopulation: PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, "number analyzed" signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Day 30
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 52.18
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
6.7 percentage of participants
Interval 0.17 to 31.95
|
—
|
|
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Day 60
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 52.18
|
25.0 percentage of participants
Interval 0.63 to 80.59
|
18.2 percentage of participants
Interval 2.28 to 51.78
|
—
|
|
Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase
Day 90
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 60.24
|
50.0 percentage of participants
Interval 1.26 to 98.74
|
27.3 percentage of participants
Interval 6.02 to 60.97
|
—
|
SECONDARY outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: PD analysis set. Here, "number analyzed" signifies the number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
|
207.50 IU/kg
Standard Deviation 8.485
|
141.85 IU/kg
Standard Deviation 23.550
|
132.40 IU/kg
Standard Deviation 12.934
|
115.06 IU/kg
Standard Deviation 17.164
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 in dose adjustment phasePopulation: PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels
|
4.5 days
Interval 4.0 to 5.0
|
3.0 days
Interval 1.0 to 7.0
|
2.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of \>=0 to \<8 weeks.
During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported.
Outcome measures
| Measure |
Dalteparin Sodium: All Participants (>= 0 to < 19 Years)
n=2 Participants
All participants who received dalteparin sodium injection, subcutaneously at a dose of 100 to 150 IU/kg twice daily from Day 1 to 7 in dose adjustment phase, Day 8-14 in PD phase and from Day 15 in follow up phase until bleeding necessitating or unexpected permanent discontinuation of anticoagulation therapy, unexpected thrombocytopenia and other adverse event necessitating discontinuation of study drug (up to a maximum of 104 days). Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=8 Participants
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=7 Participants
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=17 Participants
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels
|
3.5 dose adjustment
Interval 3.0 to 4.0
|
0.5 dose adjustment
Interval 0.0 to 2.0
|
0.0 dose adjustment
Interval 0.0 to 1.0
|
0.0 dose adjustment
Interval 0.0 to 2.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours post-dose at each Day 1 to 7 in dose adjustment phasePopulation: Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.
Outcome measures
Outcome data not reported
Adverse Events
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
Serious events: 13 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
n=1 participants at risk
Participants aged \>= 0 to \< 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 participants at risk
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 participants at risk
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 participants at risk
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 participants at risk
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intestinal haematoma
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
5/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)
n=1 participants at risk
Participants aged \>= 0 to \< 8 weeks were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 2 (>=8 Weeks to <2 Years)
n=2 participants at risk
Participants aged \>=8 weeks to \<2 years were administered 150 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 3 (>=2 Years to <8 Years)
n=8 participants at risk
Participants aged \>=2 years to \<8 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 4 (>=8 Years to <12 Years)
n=7 participants at risk
Participants aged \>=8 years to \<12 years were administered 125 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
Dalteparin Sodium: Group 5 (>=12 Years to <19 Years)
n=20 participants at risk
Participants aged \>=12 years to \<19 years were administered 100 IU/kg of dalteparin sodium injection subcutaneously twice daily from Day 1 to 7 in DA phase, Day 8 to 14 in PD phase and from Day 15 in FU phase (up to 104 days). Participants were to participate in the study for up to 104 days of study drug treatment to monitor the status of the qualifying VTE. Participants were followed up for safety for up to 28 days after last dose of study drug (up to 132 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
37.5%
3/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye swelling
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
37.5%
3/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Vein disorder
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Hypocomplementaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
2/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Catheter site bruise
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Infusion site bruising
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site bruising
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
57.1%
4/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
40.0%
8/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site haematoma
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site mass
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site nodule
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
4/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Localised oedema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Nodule
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Swelling
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Refractoriness to platelet transfusion
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infusion site cellulitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sinusitis bacteria
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Hepatitis A virus test positive
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.0%
3/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
4/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
2/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspergillus test positive
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood calcium increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Body temperature increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count increased
|
100.0%
1/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Transaminases increased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.6%
2/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
1/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
2/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.3%
1/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/1 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/8 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/7 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
1/20 • Baseline up to 28 days after the last dose of study drug (up to Day 132)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER