Trial Outcomes & Findings for A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL) (NCT NCT02509039)
NCT ID: NCT02509039
Last Updated: 2024-09-23
Results Overview
NCI CTCAE Version 4.03 will be used to grade adverse events. Events described below will be classified as DLTs: * Non-hematologic AEs: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Laboratory abnormalities: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Hematologic: Any febrile neutropenia, Grade 4 neutropenia lasting \> 7 days, Grade 4 thrombocytopenia lasting \> 24 hours or thrombocytopenia of any grade requiring platelet transfusions, Any Grade 3/4 thrombocytopenia with clinically significant bleeding * Hepatic: Grade 4 liver function tests or Grade 3 ALT with Grade 2 or higher bilirubin will be considered a DLT, irrespective of underlying attribution. Other Grade 3 LFTs due to disease progression in the liver will not be considered DLTs * Other adverse events: Suspected to be related to CC-122 and necessitating a dose reduction during the DLT evaluation period
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From first dose up to at least 28 days (Cycle 1)
Results posted on
2024-09-23
Participant Flow
15 participants treated
Participant milestones
| Measure |
AIC 2.0 mg
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
AIC 2.0 mg
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive disease
|
2
|
2
|
1
|
5
|
|
Overall Study
Study terminated by Sponsor
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
Baseline characteristics by cohort
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 4.51 • n=99 Participants
|
62 Years
STANDARD_DEVIATION 14.53 • n=107 Participants
|
68.7 Years
STANDARD_DEVIATION 8.62 • n=206 Participants
|
65.3 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 8.42 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Primary Race · Japanese
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From first dose up to at least 28 days (Cycle 1)Population: All treated participants
NCI CTCAE Version 4.03 will be used to grade adverse events. Events described below will be classified as DLTs: * Non-hematologic AEs: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Laboratory abnormalities: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Hematologic: Any febrile neutropenia, Grade 4 neutropenia lasting \> 7 days, Grade 4 thrombocytopenia lasting \> 24 hours or thrombocytopenia of any grade requiring platelet transfusions, Any Grade 3/4 thrombocytopenia with clinically significant bleeding * Hepatic: Grade 4 liver function tests or Grade 3 ALT with Grade 2 or higher bilirubin will be considered a DLT, irrespective of underlying attribution. Other Grade 3 LFTs due to disease progression in the liver will not be considered DLTs * Other adverse events: Suspected to be related to CC-122 and necessitating a dose reduction during the DLT evaluation period
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose up to at least 28 days (Cycle 1)Population: All treated participants
The MTD is defined as the last dose level below the non-tolerated dose (NTD) with zero or one out of six evaluable participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period. At least 6 participants will be enrolled at the MTD/recommended phase 2 dose (RP2D). MTD will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria Version 4.03
Outcome measures
| Measure |
AIC 2.0 mg
n=15 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
4.0 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 28 days post last dose of investigational product (Up to approximately 92 months)Population: All treated participants
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria version 4.03
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Area under the plasma concentration time-curve up to the last measurable concentration (AUC0-t)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: AUC0-t
Cycle 1 Day 1
|
634.70 ng/mL*h
Geometric Coefficient of Variation 39.2
|
590.30 ng/mL*h
Geometric Coefficient of Variation 6.2
|
953.89 ng/mL*h
Geometric Coefficient of Variation 11.0
|
982.59 ng/mL*h
Geometric Coefficient of Variation 35.9
|
|
Pharmacokinetic Parameters of CC-122: AUC0-t
Cycle 1 Day 10, 11, or 12
|
895.49 ng/mL*h
Geometric Coefficient of Variation 45.7
|
744.65 ng/mL*h
Geometric Coefficient of Variation 4.9
|
1399.3 ng/mL*h
Geometric Coefficient of Variation 2.6
|
1282.80 ng/mL*h
Geometric Coefficient of Variation 27.9
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Area under the plasma concentration time-curve during a dosing interval (AUCtau)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: AUCtau
Cycle 1 Day 1
|
634.70 ng/mL*h
Geometric Coefficient of Variation 39.2
|
590.3 ng/mL*h
Geometric Coefficient of Variation 6.2
|
953.89 ng/mL*h
Geometric Coefficient of Variation 11
|
982.59 ng/mL*h
Geometric Coefficient of Variation 35.9
|
|
Pharmacokinetic Parameters of CC-122: AUCtau
Cycle 1 Day 10, 11, or 12
|
895.49 ng/mL*h
Geometric Coefficient of Variation 45.7
|
744.65 ng/mL*h
Geometric Coefficient of Variation 4.9
|
1399.3 ng/mL*h
Geometric Coefficient of Variation 2.6
|
1282.8 ng/mL*h
Geometric Coefficient of Variation 27.9
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Peak (maximum) plasma concentration (Cmax)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: Cmax
Cycle 1 Day 1
|
52.78 ng/mL
Geometric Coefficient of Variation 30.4
|
52.26 ng/mL
Geometric Coefficient of Variation 17.4
|
73.8 ng/mL
Geometric Coefficient of Variation 20
|
107.72 ng/mL
Geometric Coefficient of Variation 42.3
|
|
Pharmacokinetic Parameters of CC-122: Cmax
Cycle 1 Day 10,11 or 12
|
72.13 ng/mL
Geometric Coefficient of Variation 34.6
|
58.88 ng/mL
Geometric Coefficient of Variation 28.6
|
112.61 ng/mL
Geometric Coefficient of Variation 24.5
|
113.54 ng/mL
Geometric Coefficient of Variation 28.7
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Time to maximum plasma concentration (Tmax)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: Tmax
Cycle 1 Day 1
|
2.24 hours
Geometric Coefficient of Variation 78.8
|
1.5 hours
Geometric Coefficient of Variation 78.5
|
1.19 hours
Geometric Coefficient of Variation 41.7
|
0.88 hours
Geometric Coefficient of Variation 46.1
|
|
Pharmacokinetic Parameters of CC-122: Tmax
Cycle 1 Day 10, 11 or 12
|
1.65 hours
Geometric Coefficient of Variation 60.1
|
1.55 hours
Geometric Coefficient of Variation 166.4
|
1.5 hours
Geometric Coefficient of Variation 78.5
|
1.28 hours
Geometric Coefficient of Variation 73.3
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Terminal half-life of CC-122 (t1/2)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: t1/2
Cycle 1 Day 1
|
11.67 hours
Geometric Coefficient of Variation 19.8
|
9.98 hours
Geometric Coefficient of Variation 19.2
|
11.67 hours
Geometric Coefficient of Variation 12.3
|
9.27 hours
Geometric Coefficient of Variation 29.9
|
|
Pharmacokinetic Parameters of CC-122: t1/2
Cycle 1 Day 10, 11 or 12
|
13.51 hours
Geometric Coefficient of Variation 28.4
|
15.5 hours
Geometric Coefficient of Variation 3
|
12.36 hours
Geometric Coefficient of Variation 11.4
|
9.7 hours
Geometric Coefficient of Variation 19.6
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Apparent clearance (CL/F)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: CL/F
Cycle 1 Day 1
|
2.84 L/h
Geometric Coefficient of Variation 35.6
|
4.11 L/h
Geometric Coefficient of Variation 3.8
|
3.17 L/h
Geometric Coefficient of Variation 15.8
|
2.53 L/h
Geometric Coefficient of Variation 34.6
|
|
Pharmacokinetic Parameters of CC-122: CL/F
Cycle 1 Day 10, 11 or 12
|
1.55 L/h
Geometric Coefficient of Variation 59.6
|
2.63 L/h
Geometric Coefficient of Variation 7.5
|
2.12 L/h
Geometric Coefficient of Variation 6.2
|
1.9 L/h
Geometric Coefficient of Variation 30.1
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Apparent volume of distribution (Vz/F)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of CC-122: Vz/F
Cycle 1 Day 1
|
47.75 L
Geometric Coefficient of Variation 15
|
59.11 L
Geometric Coefficient of Variation 18.6
|
53.46 L
Geometric Coefficient of Variation 8.5
|
33.80 L
Geometric Coefficient of Variation 46.2
|
|
Pharmacokinetic Parameters of CC-122: Vz/F
Cycle 1 Day 10, 11, or 12
|
30.29 L
Geometric Coefficient of Variation 37.4
|
58.78 L
Geometric Coefficient of Variation 4.5
|
37.82 L
Geometric Coefficient of Variation 5.2
|
26.64 L
Geometric Coefficient of Variation 31.4
|
PRIMARY outcome
Timeframe: 0, 0.5, 0.75, 1, 1.5, 3, 5, 8 and 24 hours post dose of Cycle 1 Day 1, 10, 11 or 12 (Cycle = 28 Days)Population: Pharmacokinetics (PK) population: The PK Evaluable Population includes all participants who take at least one dose of CC- 122, and have at least one measurable CC- 122 concentration datum.
Accumulation Index defined as AUCtau (Cycle 1 Day 10, 11 or 12)/AUCtau (Cycle 1 Day 1)
Outcome measures
| Measure |
AIC 2.0 mg
n=3 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=5 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Accumulation Index of CC-122
|
1.41 ng/mL*h
Geometric Coefficient of Variation 9.3
|
1.26 ng/mL*h
Geometric Coefficient of Variation 8.3
|
1.47 ng/mL*h
Geometric Coefficient of Variation 9
|
1.25 ng/mL*h
Geometric Coefficient of Variation 24.6
|
SECONDARY outcome
Timeframe: From first dose until objectively documented progression (Up to 92 Months) at Day 15 of Cycle 2, 4, 6, and every 3 cycles thereafter (Cycle = 28 Days)Population: Efficacy Evaluable (EE) population: all participants who complete at least one cycle of their assigned treatment regimen, and have a baseline and at least one post-baseline efficacy assessment
BOR by investigator is defined according to International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma for NHL patients and Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for solid tumors patients. For NHL, complete remission (CR)=disappearance of all evidence of disease. Partial response (PR)=regression of measurable disease and no new sites. Stable disease (SD)=failure to attain CR/PR or PD. Progressive disease (PD)=any new lesion or increase by \>=50% of previously sites from nadir. For solid tumors, complete response (CR)=disappearance of all target and non-target lesions and no new lesions. PR=at least a 30% decrease in the sum of diameters of target lesions and no new lesions. SD=neither sufficient shrinkage to qualify for PR or increase to qualify for PD. PD=at least 20% increase in the sum of diameters of target lesions from nadir.
Outcome measures
| Measure |
AIC 2.0 mg
n=2 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=5 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Best Overall Response (BOR)
NHL Complete Remission
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
NHL Partial Response (PR)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Best Overall Response (BOR)
NHL Stable Disease (SD)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
NHL Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
Solid Tumors Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Solid Tumors PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Solid Tumors SD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Solid Tumors PD
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose until objectively documented progression (Up to 92 Months) at Day 15 of Cycle 2, 4, 6, and every 3 cycles thereafter (Cycle = 28 Days)Population: Efficacy Evaluable (EE) population with complete response (CR) or partial response (PR): all participants who complete at least one cycle of their assigned treatment regimen, and have a baseline and at least one post-baseline efficacy assessment
DoR for NHL patients is defined as the time from the date when complete response (CR) or partial response (PR), whichever is first recorded are met, until the date when disease progression (PD) is first objectively documented, or the date of the last adequate tumor assessment when no disease progression is documented throughout the study according to International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR=disappearance of all evidence of disease. PR=regression of measurable disease and no new sites. Progressive disease (PD)=any new lesion or increase by \>=50% of previously sites from nadir.
Outcome measures
| Measure |
AIC 2.0 mg
n=2 Participants
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=2 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 Participants
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=1 Participants
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Duration of Response (DoR)
|
NA weeks
Interval 24.3 to 387.0
Median not reached as insufficient number of participants with events
|
NA weeks
Interval 133.1 to 267.7
Median not reached as insufficient number of participants with events
|
139.4 weeks
Interval 32.0 to 139.4
|
39.9 weeks
Interval 39.9 to 39.9
|
Adverse Events
AIC 2.0 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
AIC 3.0 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AIC 4.0 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
F6 3.0 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
AIC 2.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 participants at risk
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
Malaise
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary eosinophilia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
Other adverse events
| Measure |
AIC 2.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 2.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 3.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
AIC 4.0 mg
n=3 participants at risk
CC-122 administered orally at a dose of 4.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using active ingredient in capsule (AIC)
|
F6 3.0 mg
n=6 participants at risk
CC-122 administered orally at a dose of 3.0 mg on a 5 continuous days out of 7 days per week intermittent dosing schedule using formulated capsules (F6)
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Eye disorders
Eye discharge
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
Face oedema
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
Malaise
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
General disorders
Thirst
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Urinary occult blood positive
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
Weight increased
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Post herpetic neuralgia
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Mucocutaneous ulceration
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
66.7%
2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
|
Vascular disorders
Vasospasm
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
33.3%
1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 92 months.) SAEs and Other AEs was assessed from first dose to 28 days post the last dose of study therapy (up to approximately an average of 21 months and a maximum of 92 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER