Trial Outcomes & Findings for A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCT NCT02807558)
NCT ID: NCT02807558
Last Updated: 2024-12-13
Results Overview
ORR was defined as: AML: number of participants with complete remission (CR), CR with incomplete blood count recovery (CRi), CR with partial hematologic recovery (CRh), partial remission(PR), or morphologic leukemia-free state (MLFS) determined by the investigator per revised International Working Group (IWG) AML criteria. HR-MDS: the number of participants with CR, PR, marrow CR (mCR), or HI determined by the investigator per revised IWG MDS criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Up to 48 months
Results posted on
2024-12-13
Participant Flow
Screening assessments were conducted within 30 days of dosing.
Participant milestones
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
Participants with Relapsed/Refractory (R/R) Non-Acute Promyelocytic Leukemia (APL) Acute Myeloid Leukemia (AML) or R/R Higher-risk Myelodysplastic Syndrome (HR-MDS) received tamibarotene at 6 milligrams (mg)/meter (m)\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
LR-MDS: Tamibarotene Monotherapy
Participants with transfusion-dependent lower-risk myelodysplastic syndrome (LR-MDS) without the del- 5q abnormality who were refractory to erythropoietin (EPO) treatment or unlikely to respond to EPO treatment received tamibarotene at 6 mg/m\^2/day in 2 divided doses from Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants also received daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
2
|
29
|
51
|
28
|
16
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
29
|
2
|
29
|
51
|
28
|
16
|
|
Overall Study
Response Evaluable Population
|
22
|
2
|
27
|
46
|
21
|
12
|
|
Overall Study
Completed Per Study Protocol
|
29
|
2
|
29
|
51
|
27
|
16
|
|
Overall Study
Completed Post-Treatment Follow-up
|
1
|
0
|
0
|
6
|
1
|
0
|
|
Overall Study
Evaluable for Hematological Improvement (HI)
|
16
|
2
|
25
|
16
|
17
|
9
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
6
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
2
|
29
|
45
|
26
|
16
|
Reasons for withdrawal
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
Participants with Relapsed/Refractory (R/R) Non-Acute Promyelocytic Leukemia (APL) Acute Myeloid Leukemia (AML) or R/R Higher-risk Myelodysplastic Syndrome (HR-MDS) received tamibarotene at 6 milligrams (mg)/meter (m)\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
LR-MDS: Tamibarotene Monotherapy
Participants with transfusion-dependent lower-risk myelodysplastic syndrome (LR-MDS) without the del- 5q abnormality who were refractory to erythropoietin (EPO) treatment or unlikely to respond to EPO treatment received tamibarotene at 6 mg/m\^2/day in 2 divided doses from Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants also received daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Consent withdrawn by participant
|
4
|
0
|
4
|
2
|
1
|
0
|
|
Overall Study
Non-compliance with Study Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
9
|
0
|
0
|
0
|
|
Overall Study
Death
|
23
|
2
|
3
|
43
|
24
|
15
|
|
Overall Study
Progressive Disease
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other than specified
|
1
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
9
|
0
|
0
|
0
|
Baseline Characteristics
A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
LR-MDS: Tamibarotene Monotherapy
n=29 Participants
Participants with transfusion-dependent LR-MDS without the del- 5q abnormality who were refractory to EPO treatment or unlikely to respond to EPO treatment received tamibarotene at 6 mg/m\^2/day in 2 divided doses from Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
n=51 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=28 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
n=16 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants also received daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Adults (18-64 years)
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Age, Customized
From 65-84 years
|
21 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
122 Participants
n=8 Participants
|
|
Age, Customized
85 years and over
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
91 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
108 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
109 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Response Evaluable Population included participants who completed 1 cycle of study treatment, and had a follow-up assessment of disease status, and did not have any major protocol violations, or withdrew from the study before completion of Cycle 1 because of documented disease progression. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
ORR was defined as: AML: number of participants with complete remission (CR), CR with incomplete blood count recovery (CRi), CR with partial hematologic recovery (CRh), partial remission(PR), or morphologic leukemia-free state (MLFS) determined by the investigator per revised International Working Group (IWG) AML criteria. HR-MDS: the number of participants with CR, PR, marrow CR (mCR), or HI determined by the investigator per revised IWG MDS criteria.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=22 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=21 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=18 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) in Biomarker Positive AML or HR-MDS Participants Treated With Tamibarotene Monotherapy or in Combination With Azacitidine
|
2 Participants
|
0 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Population evaluable for TIR, which included all participants who received at least 8 weeks of study treatment. Here, Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
TIR was defined as the number of participants who achieved transfusion independence defined as 8 consecutive weeks of red blood cell (RBC) transfusion independence.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=27 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Transfusion Independence Rate (TIR) for LR-MDS Participants Treated With Tamibarotene Monotherapy
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
A TEAE was any untoward medical occurrence associated with use of a study drug/study participation, whether or not considered related to study drug after first dose. A TEAE was any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the study drug. A serious TEAE resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received study drug or other important medical events. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=16 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Treated With Tamibarotene in Combination With Daratumumab
TEAE
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Treated With Tamibarotene in Combination With Daratumumab
Treatment-emergent Serious Adverse Event (SAE)
|
12 Participants
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response evaluable population (which included participants who completed 1 cycle of study treatment, and had a follow-up assessment of disease status, and did not have any major protocol violations, or withdrew from the study before completion of Cycle 1 because of documented disease progression) in participants who were RARA-positive. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
ORR was defined as: AML: the number of participants with CR, CRi, CRh, PR, or MLFS as determined by the investigator per the revised IWG AML criteria. Per prespecified analysis, data were not collected for this Outcome Measure for the "R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy" arm, the "Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy" arm, and the "R/R non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab" arm as there were fewer than 5 responders per arm. Data are presented per specifications in the statistical analysis plan.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=21 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=18 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
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ORR in AML Participants Positive for the RARA Super-enhancer Associated Biomarker Treated With Tamibarotene in Combination With Azacitidine
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4 Participants
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12 Participants
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response Evaluable Population (which included participants who completed 1 cycle of study treatment, had a follow-up assessment of disease status, did not have any major protocol violations or withdrew from study before completion of Cycle 1 because of documented disease progression) in participants who were positive for the IRF8 biomarker and negative for the RARA superenhancer associated biomarker. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
ORR was defined as: AML: number of participants with CR, CRi, CRh, PR, or MLFS determined by the investigator per the revised IWG AML criteria. Per prespecified analysis, data were collected for this Outcome Measure only for the arm that enrolled the IRF8-positive participants and that included 5 or more responders. Data are presented per specifications in the statistical analysis plan.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=4 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
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|---|---|---|---|---|---|---|---|
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ORR in AML Participants Positive for the Interferon Regulatory Factor 8 (IRF8) Biomarker and Negative for the RARA Super-enhancer Associated Biomarker Treated With Tamibarotene in Combination With Azacitidine
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2 Participants
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response evaluable population included participants who completed 1 cycle of study treatment, and had a follow-up assessment of disease status, and did not have any major protocol violations, or withdrew from the study before completion of Cycle 1 because of documented disease progression. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
ORR was defined as: AML: the number of participants with CR, CRi, CRh, PR, or MLFS as determined by the investigator per the revised IWG AML criteria. Per prespecified analysis, data were collected for this Outcome Measure only for the arm that enrolled the RARA-negative participants and that included 5 or more responders. Data are presented per specifications in the statistical analysis plan.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=28 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
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|---|---|---|---|---|---|---|---|
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ORR in AML Participants Negative for the RARA Super-enhancer Associated Biomarker Treated With Tamibarotene in Combination With Azacitidine
|
12 Participants
|
—
|
—
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—
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—
|
—
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—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response evaluable population (which included participants who completed 1 cycle of study treatment, and had a follow-up assessment of disease status, and did not have any major protocol violations, or withdrew from the study before completion of Cycle 1 because of documented disease progression) who had evaluable data for the Outcome Measure.
ORR was defined as: AML: the number of participants with CR, CRi, CRh, PR, or MLFS as determined by the investigator per the revised IWG AML criteria. HR-MDS: the number of participants with CR, PR, mCR, or HI as determined by the investigator per the revised IWG MDS criteria.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=12 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
ORR for AML or HR-MDS Participants Treated With Tamibarotene in Combination With Daratumumab
|
2 Participants
|
—
|
—
|
—
|
—
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—
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—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment). Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
EFS was defined as time from first treatment until date of documentation of disease relapse following CR, CRi, or death, whichever occurred first. If the participant did not achieve a CR, EFS was defined as the point of progression or death, whichever occurred first. Per prespecified analysis, data were not collected for the Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy arm as there were fewer than 5 participants in the arm. Additionally, per prespecified analysis, data were not collected for this Outcome Measure for the LR-MDS: Tamibarotene Monotherapy arm. Data are presented per specifications in the statistical analysis plan. All-cause mortality is reported in the Reported Adverse Events module.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=28 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=16 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=22 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
n=29 Participants
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Event-Free Survival (EFS) in AML and HR-MDS Participants Treated With Tamibarotene Monotherapy, or in Combination With Azacitidine or Daratumumab
|
2.6 months
Interval 1.2 to 2.8
|
3.3 months
Interval 1.9 to 5.5
|
1.2 months
Interval 1.1 to 2.1
|
8.3 months
Interval 3.1 to 11.8
|
6.6 months
Interval 2.4 to 9.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Response evaluable population included participants who completed 1 cycle of study treatment, and had a follow-up assessment of disease status, and did not have any major protocol violations, or withdrew from the study before completion of Cycle 1 because of documented disease progression. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
DOR was defined as time from first date of response CR, CRi, CRh, MLFS or PR until the date of relapse. As prespecified, data were not collected for this Outcome Measure for any of the Tamibarotene Monotherapy arms, or R/R non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab arm. Data is presented as specified in the statistical analysis plan.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=21 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=18 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=28 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) in AML Participants Treated With Tamibarotene in Combination With Azacitidine
|
5.9 months
Interval 1.0 to
Upper confidence interval was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
10.8 months
Interval 2.9 to
Upper confidence interval was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
4.7 months
Interval 2.5 to 32.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment). Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
OS was defined as the time from first treatment until death from any cause. Per planned analysis, data were not collected for this Outcome Measure for the Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy arm as there were fewer than 5 participants in the study arm. Additionally, per prespecified analysis, data were not collected for this Outcome Measure for the LR-MDS: Tamibarotene Monotherapy arm. Data is presented as specified in the statistical analysis plan. All-cause mortality is reported in the Reported Adverse Events module.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=28 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=16 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=22 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
n=29 Participants
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) in AML and HR-MDS Participants Treated With Tamibarotene Monotherapy, or in Combination With Azacitidine or Daratumumab
|
5.7 months
Interval 2.7 to 7.1
|
5.9 months
Interval 2.7 to 11.0
|
3.6 months
Interval 1.8 to 4.6
|
8.4 months
Interval 5.2 to 15.6
|
11.7 months
Interval 6.6 to 15.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Measured in the population evaluable for HI, which included all participants who received at least 8 weeks of study treatment. Overall Number of Participants analyzed (N) = participants evaluable for this Outcome Measure.
HI was defined according to the modified IWG response criteria for MDS as the number of participants with a response (lasting at least 8 weeks) after first treatment, including erythroid response, platelet response, or neutrophil response. Data are presented per specifications in the statistical analysis plan.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=16 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=25 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=17 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
n=9 Participants
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=16 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
n=19 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Hematologic Improvement (HI) in AML, HR-MDS and LR-MDS Participants Treated With Tamibarotene Monotherapy, or in Combination With Azacitidine or Daratumumab
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
A TEAE was any untoward medical occurrence associated with use of a study drug/study participation, whether or not considered related to study drug after first dose. A TEAE was any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the study drug. A serious TEAE resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received study drug or other important medical events. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 Participants
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 Participants
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=29 Participants
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
n=51 Participants
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the retinoic acid receptor alpha (RARA) super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
n=28 Participants
Participants from the "Newly Diagnosed Non-APL AML:Tamibarotene and Azacitidine" arm who were negative for the RARA super-enhancer associated biomarker (RARA-negative) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Positive
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
ND Non-APL AML: Tamibarotene and Azacitidine: RARA-Negative
Participants from the "Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine" arm who were positive for the RARA super-enhancer associated biomarker (RARA-positive) were included in this subgroup analysis.
Participants who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs in AML and MDS Participants Treated With Tamibarotene Monotherapy or in Combination With Azacitidine
TEAE
|
29 Participants
|
2 Participants
|
29 Participants
|
51 Participants
|
27 Participants
|
—
|
—
|
|
Number of Participants With TEAEs in AML and MDS Participants Treated With Tamibarotene Monotherapy or in Combination With Azacitidine
Treatment-emergent SAE
|
16 Participants
|
2 Participants
|
15 Participants
|
43 Participants
|
20 Participants
|
—
|
—
|
Adverse Events
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
Serious events: 16 serious events
Other events: 29 other events
Deaths: 23 deaths
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
LR-MDS: Tamibarotene Monotherapy
Serious events: 15 serious events
Other events: 29 other events
Deaths: 3 deaths
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
Serious events: 43 serious events
Other events: 50 other events
Deaths: 43 deaths
R/R Non-APL AML: Tamibarotene and Azacitidine
Serious events: 20 serious events
Other events: 27 other events
Deaths: 24 deaths
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
Serious events: 12 serious events
Other events: 15 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 participants at risk
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 participants at risk
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
LR-MDS: Tamibarotene Monotherapy
n=29 participants at risk
Participants with transfusion-dependent LR-MDS without the del- 5q abnormality who were refractory to EPO treatment or unlikely to respond to EPO treatment received tamibarotene at 6 mg/m\^2/day in 2 divided doses from Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
n=51 participants at risk
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=28 participants at risk
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
n=16 participants at risk
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants also received daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Partial seizures
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Orthostatic hypotension
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Vasculitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Fatigue
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
General physical health deterioration
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cranial nerve disorder
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Hydrocephalus
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
23.5%
12/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
32.1%
9/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
43.8%
7/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Lung infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
15.7%
8/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pseudomonal sepsis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Wound infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Device related infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Lung abscess
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Malaria
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Proteus infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Serratia sepsis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Skin infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
Other adverse events
| Measure |
R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
n=29 participants at risk
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
n=2 participants at risk
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28- day cycle.
|
LR-MDS: Tamibarotene Monotherapy
n=29 participants at risk
Participants with transfusion-dependent LR-MDS without the del- 5q abnormality who were refractory to EPO treatment or unlikely to respond to EPO treatment received tamibarotene at 6 mg/m\^2/day in 2 divided doses from Days 1-28 of a 28-day cycle.
|
Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
n=51 participants at risk
Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML: Tamibarotene and Azacitidine
n=28 participants at risk
Participants with R/R non-APL AML received tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
|
R/R Non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
n=16 participants at risk
Participants with R/R non-APL AML or R/R HR-MDS received tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants also received daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
37.9%
11/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
48.3%
14/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
41.2%
21/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
28.6%
8/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
31.2%
5/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.5%
13/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
11.8%
6/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Lung infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Hallucination, Visual acuity reduced
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Genito-pelvic pain/penetration disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Hallucination, Olfactory
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Amylase increased
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Paronychia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Lip infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.1%
7/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
27.6%
8/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
47.1%
24/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
32.1%
9/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Pallor
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Vascular insufficiency
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Venous thrombosis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Hypertension
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
11.8%
6/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Deep vein thrombosis
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Haematoma
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
100.0%
2/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Hot flush
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Vascular disorders
Erythema
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Adverse drug reaction
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Asthenia
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
21.6%
11/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Catheter site erythema
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Catheter site pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Chills
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Crepitations
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Device related thrombosis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Exercise tolerance decreased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Facial pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Fatigue
|
41.4%
12/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
31.0%
9/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
37.3%
19/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
32.1%
9/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
4/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site bruising
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site haemorrhage
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Malaise
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Medical device pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Medical device site erythema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Oedema peripheral
|
27.6%
8/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
37.3%
19/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
4/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Pain
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Pyrexia
|
27.6%
8/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
33.3%
17/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
21.4%
6/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Catheter site rash
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Chest pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
General physical health deterioration
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Impaired healing
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Inflammatory pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site erythema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site irritation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site nodule
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Injection site reaction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Localised oedema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Peripheral swelling
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Catheter site swelling
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
General disorders
Early satiety
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.1%
7/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.6%
8/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.5%
13/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
21.4%
6/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
7/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Reproductive system and breast disorders
Acute promyelocytic leukaemia differentiation syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal ulcer
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
11.8%
6/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Delirium
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood cholesterol increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood creatinine increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood triglycerides increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Cardiac murmur
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Lipase decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Lipase increased
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Neutrophil count decreased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Platelet count decreased
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Respiratory rate increased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Skin turgor decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Vitamin K decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Weight decreased
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
35.3%
18/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
White blood cell count decreased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood uric acid increased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Coronavirus test positive
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Troponin I increased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Heart rate irregular
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Eye injury
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.7%
7/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Laceration
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
31.2%
5/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Congenital, familial and genetic disorders
Macroglossia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Atrial flutter
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Atrial tachycardia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Bradycardia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Nodal rhythm
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Palpitations
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Tachycardia
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cerebrovascular accident
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cranial nerve disorder
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Dizziness
|
31.0%
9/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
21.6%
11/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Dizziness postural
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Dysgeusia
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Haemorrhage intracranial
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Headache
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
11.8%
6/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Memory impairment
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Paraesthesia
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Seizure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Sinus headache
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Ageusia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Akathisia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.5%
13/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
4/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Splenic lesion
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
23.5%
12/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
37.5%
6/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
4/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Blood and lymphatic system disorders
Thymus disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
External ear pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Mastoid effusion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Cataract
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Conjunctival haemorrhage
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Dry eye
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Eye disorder
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Eye irritation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Eye pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Retinal vascular disorder
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Vision blurred
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Exophthalmos
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Photophobia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Eye disorders
Blindness
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
11.8%
6/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
47.1%
24/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
35.7%
10/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
27.6%
8/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
33.3%
17/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
39.3%
11/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Lip dry
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
47.1%
24/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
14/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
31.2%
5/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Rectal ulcer
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
21.6%
11/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
32.1%
9/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
37.5%
6/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Lip haemorrhage
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Gastrointestinal disorders
Gingival pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
34.5%
10/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
15.7%
8/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
19.6%
10/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Night sweat
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.7%
6/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
23.5%
12/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.9%
5/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Nodular rash
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Product Issues
Stasis dermatitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Sticky skin
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Chronic papillomatous dermatitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Chromaturia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Micturition urgency
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Proteinuria
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urinary tract pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Endocrine disorders
Cushingoid
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.5%
13/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
25.0%
7/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
17.6%
9/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.2%
5/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
9.8%
5/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
14.3%
4/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
18.8%
3/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.1%
7/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.7%
7/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
spinal pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Bacteraemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Cellulitis
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Clostridium bacteraemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Folliculitis
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Furuncle
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Klebsiella bacteraemia
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Klebsiella infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Oral candidiasis
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.8%
4/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Otitis externa
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Otitis media
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Perineal abscess
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Phlebitis infective
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.7%
3/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Rash pustular
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Skin infection
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Staphylococcal infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
10.3%
3/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.9%
2/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
12.5%
2/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.4%
1/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
50.0%
1/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
13.8%
4/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
5.9%
3/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
7.1%
2/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
6.2%
1/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Abscess oral
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Cystitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Device related infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
3.6%
1/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/2 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/29 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
2.0%
1/51 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/28 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
0.00%
0/16 • Up to 48 months
Safety population included all screened participants who received any amount of study drug (tamibarotene or combination treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Note that the agreements are between the clinical sites and the Sponsor (or its agents), which restrict the clinical trial sites' rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER