Trial Outcomes & Findings for A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer (NCT NCT00951665)
NCT ID: NCT00951665
Last Updated: 2016-06-24
Results Overview
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later
Results posted on
2016-06-24
Participant Flow
This study was conducted from 21 Jul 2009 to 04 Jun 2013 at 5 centers (4 centers for Phase Ib and 5 centers for Phase IIa) in the United States.
Participant milestones
| Measure |
Phase Ib Regimen 1
Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW + pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Phase 1b
STARTED
|
29
|
10
|
21
|
3
|
0
|
0
|
|
Phase 1b
Started Treatment
|
26
|
10
|
21
|
3
|
0
|
0
|
|
Phase 1b
COMPLETED
|
7
|
6
|
4
|
2
|
0
|
0
|
|
Phase 1b
NOT COMPLETED
|
22
|
4
|
17
|
1
|
0
|
0
|
|
Phase 2a
STARTED
|
0
|
0
|
0
|
0
|
22
|
22
|
|
Phase 2a
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
15
|
|
Phase 2a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
7
|
Reasons for withdrawal
| Measure |
Phase Ib Regimen 1
Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW + pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Phase 1b
Adverse Event
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Phase 1b
Death
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Phase 1b
Physician Decision
|
4
|
0
|
1
|
0
|
0
|
0
|
|
Phase 1b
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1b
Disease Progression
|
13
|
2
|
14
|
0
|
0
|
0
|
|
Phase 1b
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2a
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2a
Death
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Phase 2a
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2a
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2a
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2a
Disease Progression
|
0
|
0
|
0
|
0
|
6
|
5
|
Baseline Characteristics
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m\^2 QW + pertuzumab Q3W intravenously.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
55.1 years
STANDARD_DEVIATION 7.7 • n=8 Participants
|
53.2 years
STANDARD_DEVIATION 10.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
101 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is laterPopulation: Safety Population: All participants who received at least a single dose of study medication were included.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
Any SAEs
|
7 participants
|
5 participants
|
7 participants
|
2 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
Any AEs
|
26 participants
|
10 participants
|
21 participants
|
3 participants
|
22 participants
|
22 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
Death
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
Any AEs Grade 3
|
19 participants
|
5 participants
|
15 participants
|
2 participants
|
13 participants
|
13 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
Any AEs Grade 4
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
AEs leading to T-DM1 discontinuation
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
AEs leading to paclitaxel discontinuation
|
20 participants
|
7 participants
|
14 participants
|
3 participants
|
13 participants
|
13 participants
|
|
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death
AEs leading to pertuzumab discontinuation
|
NA participants
NA: Not applicable for this group
|
1 participants
|
NA participants
NA: Not applicable for this group
|
1 participants
|
NA participants
NA: Not applicable for this group
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 23 daysPopulation: Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included. Participants in Phase 1b (Regimen 1, Regimen 2, Regimen 3 and Regimen 4 \[60 participants\]) were considered for this analysis.
DLT is defined as one of the following toxicities related to study drug during Cycle 1, according to the NCI CTCAE, Version 3: Grade 3 or higher non-hematologic AEs; Grade 3 or higher elevation of serum bilirubin, hepatic transaminases, or alkaline phosphatase; Grade 4 or higher thrombocytopenia; Grade 4 or higher neutropenia; any subjectively intolerable toxicity related to T-DM1, paclitaxel, or pertuzumab; any treatment-related toxicity prohibiting the start of the second cycle of treatment and/or prompting to a dose delay or modification during the DLT observation period, such as prompting a dose reduction at Cycle 2 Day1.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 21Population: Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.
The MTD was defined as the highest dose of T-DM1 and paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when T-DM1 (Q3W or QW) and paclitaxel (QW) was administered with and without pertuzumab treatment.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab
|
3.6 mg/kg
|
3.6 mg/kg
|
2.4 mg/kg
|
2.4 mg/kg
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 21Population: Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.
The MTD was defined as the highest dose of paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when paclitaxel (QW) and T-DM1 (Q3W or QW) was administered with and without pertuzumab treatment.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab
|
80 mg/m^2
|
80 mg/m^2
|
80 mg/m^2
|
80 mg/m^2
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to 15 weeksPopulation: Safety Population: All participants of the phase IIa part of the study who received at least a single dose of study medication and did not have disease progression in the first 12 weeks of study treatment were included.
Participants in Phase IIa received T-DM1 Q3W and paclitaxel in Group A and T-DM1, paclitaxel, and pertuzumab in Group B.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=21 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=22 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab
|
11 participants
|
11 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is laterPopulation: Safety Population: All participants who received at least a single dose of study medication were included.
Participants were assessed for toxicity prior to each dose of T-DM1 and paclitaxel; dosing occurred only if the clinical assessment and laboratory test values were acceptable. Dose modifications included dose delayed or any dose reduction. Participants in whom significant toxicities had not recovered to the treatment range defined by the dose modification guidelines at the time of their next scheduled dose, had their dose of T-DM1 and/or paclitaxel delayed or reduced for up to 21 days.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel
T-DM1
|
13 participants
|
5 participants
|
19 participants
|
2 participants
|
15 participants
|
12 participants
|
|
Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel
Paclitaxel
|
20 participants
|
7 participants
|
14 participants
|
3 participants
|
18 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)Population: Pharmacokinetics (PK) population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
Cmax of serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=2 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=6 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=8 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=3 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
T-DM1
|
53.5 microgram per millilitre (Mcg /mL)
Standard Deviation 3.1
|
44.9 microgram per millilitre (Mcg /mL)
Standard Deviation 4.8
|
43.6 microgram per millilitre (Mcg /mL)
Standard Deviation 16.3
|
54.6 microgram per millilitre (Mcg /mL)
Standard Deviation 13.6
|
62.2 microgram per millilitre (Mcg /mL)
Standard Deviation 18.9
|
76.1 microgram per millilitre (Mcg /mL)
Standard Deviation 31.5
|
|
Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
Total trastuzumab
|
73.9 microgram per millilitre (Mcg /mL)
Standard Deviation 33.4
|
61 microgram per millilitre (Mcg /mL)
Standard Deviation 23.2
|
62 microgram per millilitre (Mcg /mL)
Standard Deviation 15.2
|
55.2 microgram per millilitre (Mcg /mL)
Standard Deviation 12.3
|
91 microgram per millilitre (Mcg /mL)
Standard Deviation 45.4
|
87.4 microgram per millilitre (Mcg /mL)
Standard Deviation 39.5
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
Cmax of plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=4 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=8 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen
|
2.4 nano gram per milliliter (ng/mL)
Interval 2.0 to 2.7
|
3.4 nano gram per milliliter (ng/mL)
Interval 2.0 to 4.9
|
2.7 nano gram per milliliter (ng/mL)
Interval 2.6 to 2.8
|
3.2 nano gram per milliliter (ng/mL)
Interval 2.6 to 4.1
|
5.1 nano gram per milliliter (ng/mL)
Interval 3.2 to 6.3
|
—
|
PRIMARY outcome
Timeframe: Pre- and post-dose (0.25 and 4 hours and Day 8 [before paclitaxel infusion) for Cycle 1 and pre- and post-dose (0.25 and 4 hours) for Cycle 2 (each cycle of 21 days)Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
AUC0-21 for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=2 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=6 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=6 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=3 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
T-DM1
|
241 day*mcg/mL
Standard Deviation 57.2
|
216 day*mcg/mL
Standard Deviation 118
|
264 day*mcg/mL
Standard Deviation 77.4
|
271 day*mcg/mL
Standard Deviation 51.2
|
382 day*mcg/mL
Standard Deviation 140
|
523 day*mcg/mL
Standard Deviation 288
|
|
Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen
Total trastuzumab
|
633 day*mcg/mL
Standard Deviation 496
|
518 day*mcg/mL
Standard Deviation 359
|
460 day*mcg/mL
Standard Deviation 308
|
401 day*mcg/mL
Standard Deviation 249
|
959 day*mcg/mL
Standard Deviation 609
|
764 day*mcg/mL
Standard Deviation 372
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
Cmax for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis when T-DM1 was administered QW.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=3 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=9 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
T-DM1
|
24.3 mcg/mL
Standard Deviation 2.61
|
26 mcg/mL
Standard Deviation 11.2
|
39.4 mcg/mL
Standard Deviation 7.09
|
63.7 mcg/mL
Standard Deviation 8.72
|
87.8 mcg/mL
Standard Deviation 75.3
|
—
|
|
Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
Total trastuzumab
|
57.8 mcg/mL
Standard Deviation 31.7
|
39.9 mcg/mL
Standard Deviation 24.1
|
66.1 mcg/mL
Standard Deviation 25.2
|
97.6 mcg/mL
Standard Deviation 45.7
|
92.1 mcg/mL
Standard Deviation 69.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25 and 4 hours post-dose on Day 1, and Day 8 (before T-DM1 dose)Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
Cmax for plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW
Outcome measures
| Measure |
Phase Ib Regimen 1
n=3 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=7 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen
|
1.0 ng/mL
Interval 0.8 to 1.2
|
1.8 ng/mL
Interval 0.8 to 2.7
|
3.0 ng/mL
Interval 2.6 to 3.8
|
2.7 ng/mL
Interval 2.2 to 3.2
|
4.0 ng/mL
Interval 2.4 to 6.9
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before T-DM1 dose)Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.
AUClast for serum T-DM1 and serum total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW
Outcome measures
| Measure |
Phase Ib Regimen 1
n=3 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=8 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=3 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
T-DM1
|
84.6 day*µg/mL
Standard Deviation 15.2
|
91.9 day*µg/mL
Standard Deviation 41.8
|
150 day*µg/mL
Standard Deviation 28.3
|
242 day*µg/mL
Standard Deviation 18
|
165 day*µg/mL
Standard Deviation 42.4
|
—
|
|
Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen
Total trastuzumab
|
275 day*µg/mL
Standard Deviation 170
|
149 day*µg/mL
Standard Deviation 94.1
|
295 day*µg/mL
Standard Deviation 121
|
460 day*µg/mL
Standard Deviation 250
|
270 day*µg/mL
Standard Deviation 62.2
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. "n" denotes number of participants who received the indicated study drug.
Plasma Cmax of paclitaxel (65 mg/m\^2 and 80 mg/m\^2) for Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1) was estimated by non-compartmental analysis.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=47 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)
80 mg, Cycle 1 (n = 18)
|
1540 ng/mL
Standard Deviation 64.4
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)
80 mg, Cycle 2 (n = 17)
|
1590 ng/mL
Standard Deviation 56.7
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)
65 mg, Cycle 1 (n = 29)
|
1430 ng/mL
Standard Deviation 53.5
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)
65 mg, Cycle 2 (n = 24)
|
1280 ng/mL
Standard Deviation 59.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. "n" denotes number of participants who received the indicated study drug.
Plasma AUC0-inf of paclitaxel (65 mg/m\^2 and 80 mg/m\^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).
Outcome measures
| Measure |
Phase Ib Regimen 1
n=47 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 1 (n = 29)
|
3440 hr*ng/mL
Standard Deviation 32.3
|
—
|
—
|
—
|
—
|
—
|
|
Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 2 (n = 24)
|
3520 hr*ng/mL
Standard Deviation 38
|
—
|
—
|
—
|
—
|
—
|
|
Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 1 (n = 18)
|
3890 hr*ng/mL
Standard Deviation 48
|
—
|
—
|
—
|
—
|
—
|
|
Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 2 (n = 17)
|
4220 hr*ng/mL
Standard Deviation 49.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. "n" denotes number of participants who received the indicated study drug.
Plasma t1/2 of paclitaxel (65 mg/m\^2 and 80 mg/m\^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).
Outcome measures
| Measure |
Phase Ib Regimen 1
n=47 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 2 (n = 24)
|
11.7 hr
Standard Deviation 25.1
|
—
|
—
|
—
|
—
|
—
|
|
An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 1 (n = 18)
|
8.94 hr
Standard Deviation 20
|
—
|
—
|
—
|
—
|
—
|
|
An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 1 (n = 29)
|
9.89 hr
Standard Deviation 17.1
|
—
|
—
|
—
|
—
|
—
|
|
An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 2 (n = 17)
|
10.8 hr
Standard Deviation 30.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. "n" denotes number of participants who received the indicated study drug.
Plasma CL of paclitaxel (65 mg/m\^2 and 80 mg/m\^2) was estimated by non-compartmental analysis for in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).
Outcome measures
| Measure |
Phase Ib Regimen 1
n=47 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 2 (n = 17)
|
23 L/hr/m^2
Standard Deviation 44.1
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 1 (n = 29)
|
20.7 L/hr/m^2
Standard Deviation 31.1
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 2 (n = 24)
|
21 L/hr/m^2
Standard Deviation 36.4
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 1 (n = 18)
|
22.8 L/hr/m^2
Standard Deviation 51.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2Population: PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. "n" denotes number of participants who received the indicated study drug.
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. Vss is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-inf\]) X (AUMC\[0-inf\])/AUC\[0-inf\]) where D is the dose of study drug, AUMC(0-inf) is the area under the first moment curve extrapolated to infinity and AUC(0-inf) is the area under the plasma concentration-time curve from time zero to infinite time. The Vss of paclitaxel (65 mg/m2 and 80 mg/m2) is observed in Cycle 1 (in the absence of T-DM1) and Cycle 2 (in the presence of T-DM1).
Outcome measures
| Measure |
Phase Ib Regimen 1
n=47 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 2 (n = 24)
|
220 L/m^2
Standard Deviation 57.3
|
—
|
—
|
—
|
—
|
—
|
|
An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
65 mg, Cycle 1 (n = 29)
|
167 L/m^2
Standard Deviation 56.3
|
—
|
—
|
—
|
—
|
—
|
|
An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 1 (n = 18)
|
166 L/m^2
Standard Deviation 78.9
|
—
|
—
|
—
|
—
|
—
|
|
An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)
80 mg, Cycle 2 (n = 17)
|
196 L/m^2
Standard Deviation 56.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (30 days prior to study dose), end of Cycle 2, and then every three cycles in Phase Ib and every four cycles in Phase IIa throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs firstPopulation: Safety Population: All participants who received at least a single dose of study medication were included.
Change in cardiac functions i.e., left ventricular ejection fraction (LVEF) and segmental wall abnormalities were assessed by echocardiogram or multigated acquisition scans. LVEF was assessed as change from baseline as 0 to \<15%, \>=15 to \<25%, \>=25%, and missing values.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Cardiac Function
LVEF, 0 to <15%
|
17 participants
|
7 participants
|
14 participants
|
3 participants
|
15 participants
|
18 participants
|
|
Number of Participants With Change From Baseline in Cardiac Function
LVEF, increase
|
8 participants
|
3 participants
|
5 participants
|
0 participants
|
5 participants
|
4 participants
|
|
Number of Participants With Change From Baseline in Cardiac Function
LVEF, >=15 to <25%
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Cardiac Function
LVEF, missing
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Cardiac Function
New segmental wall abnormality
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs firstPopulation: An efficacy population: All participants who received at least a single dose of study medication were included. Participants with measurable disease were considered for OR.
Participants with measurable disease (at least one lesion 2 centimeters \[cm\] or more on computed tomography (CT) scan or 1 cm or more on spiral CT scan) were considered for OR. ORR is defined as the percentage of patients with a complete response (CR)/partial response (PR) determined on two consecutive tumor assessments at least 4 weeks apart based on modified Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR defined as at least 30 percent decrease in sum of the longest diameters of the target lesions taking as reference the baseline sum longest diameters.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=24 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=18 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=21 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=21 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
50.0 percentage of participants
|
70.0 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
47.6 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs firstPopulation: An efficacy population: All participants who received at least a single dose of study medication were included. Participants with OR were considered for this outcome measure.
Duration of OR is only calculated for participants with OR and is defined as the time from the first tumor assessment that supports the participant's OR to disease progression or death.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=12 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=7 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=9 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=2 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=10 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=11 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Duration of Objective Response
|
7.1 months
Interval 4.2 to
Not estimable due to limited follow-up.
|
NA months
Interval 5.8 to
Not estimable due to limited follow-up.
|
7.0 months
Interval 4.8 to
Not estimable due to limited follow-up.
|
NA months
Not estimable due to limited follow-up.
|
NA months
Not estimable due to limited follow-up.
|
NA months
Not estimable due to limited follow-up.
|
SECONDARY outcome
Timeframe: Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs firstPopulation: An efficacy population: All participants who received at least a single dose of study medication were included.
Clinical benefit is defined as CR, PR, or stable disease (SD) of 6 months or more duration as assessed by the investigator. CR and PR are identified in previous outcome measure. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Benefit
|
65.4 percentage of participants
|
80.0 percentage of participants
|
61.9 percentage of participants
|
66.7 percentage of participants
|
54.5 percentage of participants
|
59.1 percentage of participants
|
SECONDARY outcome
Timeframe: Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs firstPopulation: An efficacy population: All participants who received at least a single dose of study medication were included.
PFS is defined as the time from the first day of study treatment to documented disease progression or death on study i.e., death due to any cause within 30-days of last dose of study treatment, whichever occurs first.
Outcome measures
| Measure |
Phase Ib Regimen 1
n=26 Participants
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 Participants
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 Participants
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 Participants
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 Participants
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 Participants
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
11.7 months
Interval 1.3 to 13.0
|
11.9 months
Interval 4.3 to 12.3
|
11.3 months
Interval 1.7 to 12.0
|
11.0 months
Interval 1.3 to 12.2
|
6.0 months
Interval 0.1 to 10.0
|
6.6 months
Interval 2.6 to 8.4
|
Adverse Events
Phase Ib Regimen 1
Serious events: 7 serious events
Other events: 26 other events
Deaths: 0 deaths
Phase Ib Regimen 2
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase Ib Regimen 3
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Phase Ib Regimen 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase IIa Group A
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Phase IIa Group B
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ib Regimen 1
n=60 participants at risk；n=26 participants at risk
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 participants at risk
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 participants at risk
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 participants at risk
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 participants at risk
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 participants at risk
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Death - unknown cause
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Thrombosis in device
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Ulcer
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Fatigue
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Chills
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Device occlusion
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Immune system disorders
Hypersensitivity
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Cellulitis
|
7.7%
2/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Device related infection
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Influenza
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Akathisia
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Psychiatric disorders
Mental Status Changes
|
3.8%
1/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/26 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
Other adverse events
| Measure |
Phase Ib Regimen 1
n=60 participants at risk；n=26 participants at risk
Participants received T-DM1 Q3W + paclitaxel QW intravenously.
|
Phase Ib Regimen 2
n=10 participants at risk
Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase Ib Regimen 3
n=21 participants at risk
Participants received T-DM1 QW + paclitaxel QW intravenously.
|
Phase Ib Regimen 4
n=3 participants at risk
Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
|
Phase IIa Group A
n=22 participants at risk
Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW intravenously.
|
Phase IIa Group B
n=22 participants at risk
Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m\^2 QW, plus pertuzumab Q3W intravenously.
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
38.3%
23/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
80.0%
8/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
85.7%
18/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
72.7%
16/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
86.4%
19/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Mucosal Inflammation
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Oedema Peripheral
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Pyrexia
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
7/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Chills
|
0.00%
0/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Chest pain
|
0.00%
0/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
General disorders
Gait disturbance
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
10/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
60.0%
6/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
38.1%
8/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
27.3%
6/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
50.0%
11/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
5/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
70.0%
7/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
28.6%
6/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
40.9%
9/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
6/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
28.6%
6/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
31.8%
7/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
9/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
60.0%
6/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
42.9%
9/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
50.0%
11/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Cellulitis
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Herpes zoster
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Infections and infestations
Eye infection
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
7/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
40.9%
9/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
31.8%
7/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.7%
7/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
27.3%
6/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.7%
7/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
38.1%
8/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
31.8%
7/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
5/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
7/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Psychiatric disorders
Depression
|
11.7%
7/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Psychiatric disorders
Insomnia
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Psychiatric disorders
Anxiety
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Haemoglobin decreased
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Weight increased
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Investigations
Weight decreased
|
0.00%
0/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Vascular disorders
Hot flush
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
6/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
23.8%
5/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
7/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
36.4%
8/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
36.4%
8/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Dry eye
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
42.9%
9/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
27.3%
6/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
54.5%
12/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Vision blurred
|
8.3%
5/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
28.6%
6/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
27.3%
6/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
27.3%
6/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Lacrimation increased
|
10.0%
6/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Conjunctivitis
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Photophobia
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Eye disorders
Visual impairment
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.8%
1/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Neuropathy peripheral
|
36.7%
22/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
80.0%
8/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
85.7%
18/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
100.0%
3/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
90.9%
20/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
86.4%
19/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.1%
2/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Headache
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
23.8%
5/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Paraesthesia
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
50.0%
5/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
38.1%
8/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
66.7%
2/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
50.0%
11/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
7/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
47.6%
10/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
40.9%
9/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
40.9%
9/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
8/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
30.0%
3/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
14.3%
3/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
18.2%
4/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
5/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
28.6%
6/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
33.3%
1/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
19.0%
4/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
22.7%
5/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
4/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
3/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
20.0%
2/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
2/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
4.5%
1/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Stomatitis
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
9.5%
2/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/60 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
10.0%
1/10 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/21 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/3 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
0.00%
0/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
13.6%
3/22 • Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later (Approximately 4 years)
SAEs and other AEs were collected in the safety population, which was defined as all participants who received at least a single dose of study medication. There was one SAE that lead to death and the preferred term was not captured for it. The same SAE was captured as 'Death - unknown cause' in the below SAE table.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER